Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
740
Countries
3
Sites
26
Colon cancer
To prove that a personalized ctDNA-guided genomic-based targeted treatment strategy can improve the clinical outcome of Stage III and High-Risk Stage II CC patients as respect to a conventional adjuvant chemotherapy approach.
Key facts
- Sponsor
- Ifom Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Oct 2024 → ongoing
- Decision date (initial)
- 2024-11-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- HORIZON-RIA HORIZON Research and Innovation Actions - HORIZON-MISS-2022-CANCER-01, Project 101104657
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacoeconomic, Therapy, Diagnosis
To prove that a personalized ctDNA-guided genomic-based targeted treatment strategy can improve the clinical outcome of Stage III and High-Risk Stage II CC patients as respect to a conventional adjuvant chemotherapy approach.
Secondary objectives 4
- To compare the 2-year RFS of the physician choice strategy versus downsized treatment in ctDNA-negative patients (Trial-2).
- To compare the toxicity and quality of life of personalized versus conventional adjuvant strategies (Trial-1 and Trial-2).
- To compare the economic toxicity of personalized versus conventional adjuvant strategies.
- To establish the false negative rate of serial LBs in the experimental arms of Trial-1 and Trial-2.
Conditions and MedDRA coding
Colon cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10010034 | Colorectal cancer stage III | 100000004864 |
| 21.0 | PT | 10010033 | Colorectal cancer stage II | 100000004864 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Trial-1 Patients resulting ctDNA positive (ctDNA+) at the post-surgery LB#A will be first stratified by MSI/MMR status and RAS/RAF mutations.
|
Randomised Controlled | None | Strata 1: MSS/MMRp patients with extended RAS/RAF mutations will be randomized 1:1 to receive standard therapy (CAPOX/FOLFOX for 6 months or until toxicity) or to a personalized treatment including CAPOX for 3 months with an interventional LB#B at the end of the treatment. Patients still resulting ctDNA+ at LB#B will be switched to a TAILORED THERAPY for 6 months or until toxicity. On the other hand, ctDNA- patients at LB#B will continue CAPOX up to 3 months, and their ctDNA status will be re-assessed at the end of the treatment. Patients remaining ctDNA- will enter into follow-up, while patients resulting ctDNA+ will be switched to the TAILORED THERAPY as mentioned above. Strata 2: MSI-H/MMRd and MSS/MMRp patients with no RAS/RAF mutations (thus wild-type) will be randomized 1:1 to receive standard therapy (CAPOX/FOLFOX for 6 months or until toxicity) or to a TAILORED THERAPY for 3 months. At the end of the TAILORED THERAPY the ctDNA status of patients will be reassessed to further guide their subsequent treatments. Patients still ctDNA+ at LB#B will be switched to CHEMOTHERAPY. On the other hand, patients undergoing seroconversion (ctDNA- at LB#B) will continue the same therapy for 3 further months and will be then re-assessed at the end of the treatment with the LB#C. Patients resulting ctDNA- will enter into Follow-up, while patients resulting ctDNA+ will be switched to the CHEMOTHERAPY regimens as mentioned above. |
|
| 2 | Trial-2 Patients resulting ctDNA negative (ctDNA-) at the post-surgery LB will be randomized 1:1 to receive a physician choice strategy (CAPE/CAPOX/FOLFOX/5-FU±LV or no treatment) up to 6 months or to an INTENSIVE FOLLOW-UP for 6 months (except for MSS Stage III High-risk patients which will be treated with CAPE). 2 interventional LBs will be performed after 2 and 4 months, and in case of positivity, patients will be switched to Trial-1.
|
Randomised Controlled | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- SAGITTARIUS trial written informed consent.
- Age ≥ 18 years.
- Histologically confirmed diagnosis of operable stage III and High-Risk stage II colon cancer located at least 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery.
- Availability of the primary tumor tissue FFPE.
- ECOG performance status 0-1.
- Normal organ functions (as defined in section 8.3 of the Protocol).
- Women with childbearing potential (WOCBP) should complete a pregnancy test and be willing to use highly effective contraceptive methods.
Exclusion criteria 14
- History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Clinically relevant cardiovascular disease.
- Acute or subacute intestinal occlusion or history of inflammatory bowel disease or any other autoimmune disease.
- Has a medical condition that contraindicate the use of the investigational medicinal product (IMP) according to product indications.
- Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment.
- Prior neoadjuvant treatment administered before surgery.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection
- Has a known history of active TB (Bacillus Tuberculosis).
- Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage).
- Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- Inadequate contraception (male or female patients) if of childbearing or procreational potential.
- Current or recent treatment with another investigational drug or participation in another investigational study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 2-year RFS in patients with a post-surgery ctDNA positivity randomized 1:1 to receive either a conventional adjuvant chemotherapy or a personalized targeted treatment strategy.
Secondary endpoints 6
- 2-year RFS in patients with a post-surgery ctDNA negativity randomized 1:1 to receive either a physician-choice strategy or an intensive follow-up strategy.
- 3 and 5-year RFS and OS in patients with a post-surgery ctDNA positivity (Trial-1) and ctDNA negativity (Trial-2) randomized either in the conventional or experimental Trials.
- Safety and tolerability according to Clinical Trials Criteria for Adverse Events (CTCAE) version 5.0 (Trial-1, Trial-2 and whole study population).
- Number of false negative cases after three consecutive negative LBs, defined as cases that experience radiological relapse within 2 years.
- Number of patients experiencing ctDNA seroconversion (i.e., ctDNA+ that become ctDNA-) after any therapy regimen remaining disease free at 2 and 3 years
- Assessment of FACT-C and EQ-5D-5L questionnaires in the whole study population.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 16
SUB07721MIG · Substance
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 1600 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2800 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 35000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 35000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB122750 · Substance
- Active substance
- Nivolumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 3 mg/kg milligram(s)/kilogram
- Max total dose
- 3 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08295MIG · Substance
- Active substance
- Irinotecan
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 200 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 750 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/square meter
- Max total dose
- 750 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 750 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06054MIG · Substance
- Active substance
- Calcium Levofolinate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB63746 · Substance
- Active substance
- Disodium Levofolinate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13910MIG · Substance
- Active substance
- Folinic Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/square meter
- Max total dose
- 400 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09490MIG · Substance
- Active substance
- Oxaliplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 85 mg/m2 milligram(s)/sq. meter
- Max total dose
- 170 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12612MIG · Substance
- Active substance
- Trastuzumab
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 8 mg/kg milligram(s)/kilogram
- Max total dose
- 8 mg/kg milligram(s)/kilogram
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Label modified for clinical trial use
SUB25390 · Substance
- Active substance
- Panitumumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 6 mg/kg milligram(s)/kilogram
- Max total dose
- 6 mg/kg milligram(s)/kilogram
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16455MIG · Substance
- Active substance
- Pertuzumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 840 mg milligram(s)
- Max total dose
- 840 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Label modified for clinical trial use
SUB29397 · Substance
- Active substance
- Ipilimumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1 mg/kg milligram(s)/kilogram
- Max total dose
- 1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ifom Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets
- Sponsor organisation
- Ifom Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets
- Address
- Via Adamello 16
- City
- Milan
- Postcode
- 20139
- Country
- Italy
Scientific contact point
- Organisation
- Ifom Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets
- Contact name
- Silvia Marsoni
Public contact point
- Organisation
- Ifom Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets
- Contact name
- Silvia Marsoni
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Jsb Solutions S.r.l. ORG-100042742
|
Sesto Fiorentino, Italy | On site monitoring, Code 12, Interactive response technologies (IRT), Code 5, Data management, E-data capture, Code 8 |
| DataRiver ORL-000005035
|
Modena, Italy | E-data capture |
| Cogentech Ltd with a single Stakeholder Foundation IFOM ETS ORL-000004518
|
Milan, Italy | Other, Laboratory analysis |
| Logista Pharma S.A. ORG-100012314
|
Leganes, Spain | Code 14 |
| Vall D Hebron Institute Of Oncology ORG-100011442
|
Barcelona, Spain | On site monitoring |
| Natera Inc. ORG-100045860
|
San Carlos, United States | Other, Laboratory analysis |
| Roche Farma S.A. ORG-100003548
|
Getafe, Spain | Other |
Locations
3 EU/EEA countries · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 40 | 1 |
| Italy | Ongoing, recruiting | 350 | 12 |
| Spain | Ongoing, recruiting | 350 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Charite Research Organisation GmbH
Division of Oncology and Hematology, Chariteplatz 1, Mitte, Berlin
Humanitas Research Hospital
Unità di Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero-Universitaria Maggiore Della Carita
S.C.D.U. Oncologia, Corso Giuseppe Mazzini 18, 28100, Novara
ASST Grande Ospedale Metropolitano Niguarda
SC Oncologia Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Hospital Santa Maria Della Misericordia
S.C. di Oncologia Medica, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Ospedaliero Universitaria Parma
Unità di Gastroenterologia ed Endoscopia Digestiva, Viale Antonio Gramsci 14, 43126, Parma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Scienze Mediche e Chirurgiche Addominali ed Endocrino Metaboliche, Largo Francesco Vito 1, 00168, Rome
Azienda Sanitaria Locale Della Provincia Di Biella
S.C. Oncologia, Via Dei Ponderanesi 2, 13875, Ponderano
Fondazione Poliambulanza
U.O. Oncologia Medica, Via Leonida Bissolati 57, 25124, Brescia
European Institute Of Oncology S.r.l.
Divisione Oncologia Medica Gastrointestinale e Tumori Neuroendocrini, Via Giuseppe Ripamonti 435, 20141, Milan
IRCCS Ospedale Policlinico San Martino
U.O. Oncologia Medica 1, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Unita Sanitaria Locale Della Romagna
UO di Oncologia di Ravenna, Lugo e Faenza, Via Alcide De Gasperi 8, 48121, Ravenna
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Oncologia Medica - Day Hospital, Strada Provinciale 142 Km 3,95, 10060, Candiolo
Institut Catala D'oncologia
Oncología Médica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Unviersitario Miguel Servet
Oncología Médica, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Marques De Valdecilla
Oncología Médica, Avenida Valdecilla Sn, 39008, Santander
Hospital Del Mar
Oncología Médica, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Complexo Hospitalario Universitario De Santiago
Oncología Médica, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Clinico San Carlos
Oncología Médica, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital General Universitario Reina Sofia
Oncología Médica, Avenida Menendez Pidal S/n, 14004, Cordoba
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
Oncología Médica, Calle De San Quintin 77-79, 08041, Barcelona
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Oncología Médica, Avenida Menendez Y Pelayo 4, 46010, Valencia
Vall D Hebron Institute Of Oncology
Oncología Médica, Calle Natzaret 115, 08035, Barcelona
Hospital General Universitario De Valencia
Oncología Médica, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Universitario De Navarra
Oncología Médica, Irunlarrea Kalea 3, 31008, Pamplona
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1, 08208, Sabadell
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2025-05-22 | 2025-05-22 | |||
| Italy | 2024-10-22 | 2024-10-22 | |||
| Spain | 2024-11-15 | 2024-11-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 86 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-509851-15-00 redacted | 4.0 |
| Protocol (for publication) | D4_Patient facing documents_Diary of the Care Path_DEU_ger redacted | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Diary of the Care Path_ENG_eng redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Diary of the Care Path_ESP_spa redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Diary of the Care Path_ITA_ita redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Diet Monitoring Questionnaire DEU_ger | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Diet Monitoring Questionnaire ESP_spa | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Diet Monitoring Questionnaire ITA_ita | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Diet Monitoring Questionnaire_ENG_eng | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Health Cost Questionnaire DEU_ger | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Health Cost Questionnaire EN_eng | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_Health Cost Questionnaire ESP_spa | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Health Cost Questionnaire ITA_ita | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_Instruction for stool samples_DEU_ger | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Instruction for stool samples_ENG_eng | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Instruction for stool samples_ESP_spa | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Instruction for stool samples_ITA_ita | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Diary Capecitabin DEU_ger_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Diary Capecitabina ESP_spa redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Diary Capecitabina ITA_ita redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Diary Capecitabine ENG_eng redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Diary Temozolomid DEU_deu_redacted | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Diary Temozolomida ESP_spa redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Diary Temozolomide ENG_eng redacted | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Diary Temozolomide ITA_ita redacted | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Leaflet_DEU_ger | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Leaflet_ENG_eng | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Leaflet_ESP_spa | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Leaflet_ITA_ita | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L Paper Interviewer Administration DEU_ger_red | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L Paper Interviewer Administration ENG_eng_redac | 1.7 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L Paper Interviewer Administration ESP_spa_redac | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L Paper Interviewer Administration ITA_ita_redac | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L Paper Self-Complete DEU_ger_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L Paper Self-Complete ENG_eng_redacted | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L Paper Self-Complete ESP_spa_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L Paper Self-Complete ITA_ita_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire FACT-C DEU_ger_redacted | 4 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire FACT-C ENG_eng_redacted | 4 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire FACT-C ESP_spa_redacted | 4 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire FACT-C ITA_ita_redacted | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Draft website copy DEU_ger | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Draft website copy ESP_spa | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Draft website copy ITA_ita | 2 |
| Recruitment arrangements (for publication) | Participating Centres List 2023-509851-15-00 | 3.0 |
| Recruitment arrangements (for publication) | Participating Centres List 2023-509851-15-00 | 3 |
| Recruitment arrangements (for publication) | Participating Centres List 2023-509851-15-00 | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults DEU_ger | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults ESP_spa | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults ITA_ita | 5.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP letter ITA_ita | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC 5-FU | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Capecitabine DEU_ger | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Capecitabine ESP_spa | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Capecitabine ITA_ita | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ipilumumab | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Irinotecan DEU_ger | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Irinotecan ESP_spa | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Irinotecan ITA_ita | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Leucovorin DEU_ger | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nivolumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nivolumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nivolumab | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nivolumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nivolumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Oxaliplatin DEU_ger | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Oxaliplatin ESP_spa | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Oxaliplatin ITA_ita | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Panitumumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pertuzumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Temozolomide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Trastuzumab | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Calcio levofolinato_ITA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Folinato calcico_SPA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Sodio Levofolinato_ITA | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol lay summary synopsis DEU 2023-509851-15-00_ger | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol lay summary synopsis ENG 2023-509851-15-00_eng | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol lay summary synopsis ESP 2023-509851-15-00_spa | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol lay summary synopsis ITA 2023-509851-15-00_ita | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DEU 2023-509851-15-00_ger | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG 2023-509851-15-00_eng | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ESP 2023-509851-15-00_spa | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ITA 2023-509851-15-00_ita | 4.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-09 | Spain | Acceptable 2024-05-29
|
2024-05-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-14 | Spain | Acceptable 2024-07-23
|
2024-07-23 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-08-20 | Acceptable 2024-07-23
|
2024-11-18 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-30 | Spain | Acceptable 2025-07-02
|
2025-07-04 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-01 | Spain | Acceptable 2025-11-03
|
2025-11-04 |