Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
93
Countries
1
Sites
5
High Risk Rectal Cancer
To determine the rate of Pathological Complete Remission (pCR) after Induction Chemotherapy followed by radiochemotherapy and consolidation chemotherapy in patients with High Risk Rectal Carcinoma.
Key facts
- Sponsor
- Centro Di Riferimento Oncologico Di Aviano
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Nov 2022 → 8 Sep 2025
- Decision date (initial)
- 2024-09-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517183-31-00
- EudraCT number
- 2020-002727-11
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To determine the rate of Pathological Complete Remission (pCR) after Induction Chemotherapy followed by radiochemotherapy and consolidation chemotherapy in patients with High Risk Rectal Carcinoma.
Secondary objectives 9
- Evaluating the feasibility of the therapeutic programme (defined as the percentage of patients that are able to complete the entire therapeutic programme in respect to the number of patients enrolled in the study)
- Evaluating the rate of Resectability R0
- Evaluating complete and partial clinical remissions (ycCR1 and ycPR1) after induction chemotherapy.
- Evaluating ycCR2 and ycPR2 after Radiochemotherapy and Consolidation Chemotherapy
- Evaluating the "Tumor Downstaging", defined as the comparison between the first clinical evaluation and the pathological re-evaluation after pre-surgical treatment
- Evaluating the Toxicity and Safety profile at every therapeutic phase following NCI-CTCAE criteria
- Evaluating Morbidity and Mortality (Clavien-Dindo) of the surgical treatment done at the end of the therapeutic programme (32-34th week)
- Evaluating the Local Control, DFS and OS at 2-5 years
- Evaluating the treatment impact on the patient's Quality of Life (EORTC QLQ-C30 and CR29)
Conditions and MedDRA coding
High Risk Rectal Cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 12
- Medial-distal Rectal Adenocarcinoma (up to 12 cm from the anal margin) histologically documented, stage T3c-dN1-2M0, MRF+, T4N0-2MO (potentially resectable), EMVI -/+
- Age > 18
- ECOG PS 0-1
- Measurable disease according to RECIST 1.1
- Able to comprehend risks and advantages of the study
- Neutrophils ≥ 1.5x10^3/μL; Platelets ≥ 100x10^3/μL; Total Bilirubin ≤ 1.5 (UNL); ALT and AST ≤ 2.5 UNL, Alkaline Phosphatase ≤ 2.5 UNL; Creatinine clearance >50 ml/min or Creatinine ≤ 1.5 UNL; Proteinuria (stick) <2+ (se ≥ 2+, perform a 24h urine collection and verify that the value is ≤1 g/24 hr).
- Absence of mutational state with complete deficit of dihydropyrimidine dehydrogenase (DPD) enzyme; presence of mutations associed with partial DPD deficit does not exclude patient eligibility (Fluoropyrimidine dose reduction is expected)
- Absence of neuropathy grade > 1 associated to concomitant illnesses
- Absence of other malignancies within the last 5 years, except for skin carcinoma and carcinoma in situ of the cervix.
- Absence of clinically significant cardiopathy
- Absence of pregnancy or ongoing breast-feeding
- Written informed consent
Exclusion criteria 4
- Previous radiotherapy on the pelvis
- Clinically significant (active) cardiovascular disease, eg. cerebrovascular events (≤6 months), myocardial infarction (≤6 months), unstable angina, congestive decompensation of grade II or higher according to New York Heart Association (NYHA), cardiac arrhythmia under therapy.
- Presence of genotypes associated with complete DPD enzyme deficiency
- Gastrointestinal disorders with malabsorption syndrome, inability to take drugs through oral administration
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pathological Complete Remissions (pCR)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP131876 · ATC
- Active substance
- Capecitabine
- Route of administration
- ORAL
- Max daily dose
- 2000 mg/m2 milligram(s)/square meter
- Max total dose
- 2000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 17 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP128961 · ATC
- Active substance
- Oxaliplatin
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 130 mg/m2 milligram(s)/square meter
- Max total dose
- 130 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centro Di Riferimento Oncologico Di Aviano
- Sponsor organisation
- Centro Di Riferimento Oncologico Di Aviano
- Address
- Via Franco Gallini 2
- City
- Aviano
- Postcode
- 33081
- Country
- Italy
Scientific contact point
- Organisation
- Centro Di Riferimento Oncologico Di Aviano
- Contact name
- Marco Gigante
Public contact point
- Organisation
- Centro Di Riferimento Oncologico Di Aviano
- Contact name
- Marco Gigante
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 93 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Universita' Degli Studi G. D'Annunzio Di Chieti
SOC Radioterapia Oncologica, Via Dei Vestini 31, 66100, Chieti
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
SOC Radioterapia Oncologica-Gemelli ART, Largo Agostino Gemelli 8 00168 Roma, Italy, roma
Centro Di Riferimento Oncologico Di Aviano
SOC Oncologia Radioterapica, Via Franco Gallini 2, 33081, Aviano
Istituto Oncologico Veneto
SOC Oncologia Medica, Via Gattamelata 64, 35128, Padova
Hospital Santa Maria Della Misericordia
SOC Radioterapia Oncologica, Piazzale Giorgio Menghini 1, 06129, Perugia
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 |
|---|---|---|---|---|---|
| Italy | 2022-11-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocollo BRIDGE-2 vs 0 del 29Gennaio2021 | 0 |
| Recruitment arrangements (for publication) | BRIDGE-2_blank statement | 1 |
| Subject information and informed consent form (for publication) | Foglio informativo e CI alla privacy GDPR_vs 0_1 CRO_13Giugno2022 | 0.1 |
| Subject information and informed consent form (for publication) | Foglio informativo e CI_BRIDGE-2_Studi Traslazionali_vs 0_2 18Ottobre2022 | 0.2 |
| Subject information and informed consent form (for publication) | Foglio informativo e CI_BRIDGE-2_vs0_2_18Ottobre2022 | 0.2 |
| Summary of Product Characteristics (SmPC) (for publication) | 15 RCP Oxaliplatino TEVA 200mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 16 RCP Capecitabina MEDAC 500mg 150mg | 1 |
| Synopsis of the protocol (for publication) | Sinossi BRIDGE-2 vs 0 del 29 Gennaio2021 | 0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-29 | Italy | Acceptable 2024-09-24
|
2024-09-30 |