Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
381
Countries
3
Sites
6
Colorectal cancer with metastasis
The primary aim of the present study is to investigate - in a randomized trial - the clinical utility of circulating tumor DNA analysis to guide treatment decisions in oligometastatic colorectal cancer
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Sep 2021 → ongoing
- Decision date (initial)
- 2023-12-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Kræftfonden · Sygeforsikringen "danmark" · DCCC ctDNA Research Renter Denmark · The Danish Cancer Society
External identifiers
- EU CT number
- 2023-509814-12-00
- EudraCT number
- 2020-004524-41
- ClinicalTrials.gov
- NCT04680260
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary aim of the present study is to investigate - in a randomized trial - the clinical utility of circulating tumor DNA analysis to guide treatment decisions in oligometastatic colorectal cancer
Secondary objectives 1
- Secondary aims include investigating molecular biological response to chemotherapy, cost effectiveness, quality of life in patients tested for circulating tumour-marker positivity.
Conditions and MedDRA coding
Colorectal cancer with metastasis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Radical intended treatment for metastatic spread from colorectal cancer, by resection, RFA, SBRT (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)
- No evidence of further disease based on pre-treatment work-up according to standard of care
- Age at least 18 years
- ECOG performance status 0-2
- Clinically eligible for adjuvant triple CT at investigators decision
- Adequate bone marrow, liver and renal function allowing systemic chemotherapy (absolute neutrophil count ≥1.5x10^9/l and thrombocytes ≥ 100x10^9/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and calculated or measured renal glomerular filtration rate at least 30 mL/min)
- Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject’s male partner or hormonal contraceptive are acceptable
- Written and verbally informed consent
Exclusion criteria 4
- Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1
- Other malignant tumour within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri
- Pregnant (positive pregnancy test) or breast feeding women
- Intolerance or allergy to fluoropyrimidine, leucovorin, oxaliplatin or irinotecan
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Rate of patients free from recurrent colorectal cancer at 2 years after inclusion
Secondary endpoints 9
- Rate of CTCAE grade 3-5 toxicity 6 months post-treatment
- Molecular biological response to therapy after 6 months
- Molecular biological disease-free survival at 1 year
- Time to molecular biological recurrence
- Time to radiological recurrence
- Local and distant relapse
- Overall survival
- QoL (EQ-5D-5L, EORTC QLQ–C30 and –CR29, explorative ctDNA utility questionnaire)
- Cost-effective analysis
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SCP128961 · ATC
- Active substance
- Oxaliplatin
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 85.00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 680.00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1165178 · ATC
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1669.57 mg/m2 milligram(s)/sq. meter
- Max total dose
- 36800.00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP105621456 · ATC
- Active substance
- Irinotecan Hydrochloride
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 165.00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1320.00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CE02 — IRINOTECAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP107133400 · ATC
- Active substance
- Calcium Folinate
- Substance synonyms
- LEUCOVORIN CALCIUM
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400.00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 3200 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AF03 — CALCIUM FOLINATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
SCP131876 · ATC
- Active substance
- Capecitabine
- Route of administration
- ORAL USE
- Max daily dose
- 2500.00 mg/m2 milligram(s)/sq. meter
- Max total dose
- 280000.00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP26523418 · ATC
- Active substance
- Tegafur
- Substance synonyms
- N1-(2-TETRAHYDROFURYL)-5-FLUOROURACIL
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg/m2 milligram(s)/sq. meter
- Max total dose
- 3360 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC53 — TEGAFUR, COMBINATIONS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Karen-Lise Garm Spindler
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Karen-Lise Garm Spindler
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Næstved Hospital ORG-100028440
|
Næstved, Denmark | Laboratory analysis |
| Sygehus Lillebaelt Vejle Sygehus ORG-100031262
|
Vejle, Denmark | Laboratory analysis |
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 350 | 4 |
| Germany | Authorised, recruitment pending | 16 | 1 |
| Norway | Ongoing, recruiting | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Lillebaelt Hospital
Danish Colorectal Cancer Center South, Department of Oncology, Beriderbakken 4, 7100, Vejle
Region Midtjylland
Oncology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Region Sjaelland
Clinical Oncology, Sygehusvej 10, 4000, Roskilde
Asklepios Kliniken Hamburg GmbH
Onkologie und Palliativmedizin mit Sektionen Hämatologie und Rheumatologie, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
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 |
|---|---|---|---|---|---|
| Denmark | 2021-09-22 | 2021-10-25 | |||
| Norway | 2025-06-06 | 2025-06-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 38 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-509814-12-00 | 2.3 |
| Protocol (for publication) | D1_Protocol 2023-509814-12-00 TC | 2.3 |
| Protocol (for publication) | D4_Patient facing document CR29 Danish | 2.1 |
| Protocol (for publication) | D4_Patient facing document CR29 English | 2.1 |
| Protocol (for publication) | D4_Patient facing document CR29 German | 3.0 |
| Protocol (for publication) | D4_Patient facing document ctDNA utility questionnaire English Danish | 1.0 |
| Protocol (for publication) | D4_Patient facing document ctDNA utility questionnaire_German | 1.0 |
| Protocol (for publication) | D4_Patient facing document EQ-5D-5L Danish | 1.1 |
| Protocol (for publication) | D4_Patient facing document EQ-5D-5L German | 1 |
| Protocol (for publication) | D4_Patient facing document QLQ-C30 Danish | 3.0 |
| Protocol (for publication) | D4_Patient facing document QLQ-C30 English | 3.0 |
| Protocol (for publication) | D4_Patient facing document QLQ-C30 German | 3.0 |
| Protocol (for publication) | D4_Patientfacing document EQ-5D-5L English | 1.1 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Germany | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Norway | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Norway_track changes | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Danish | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Danish TC | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future research German | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future research Norwegian | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF German | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF German_track changes | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Norwegian | 4.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Rettigheder som forsgsperson | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Calcium Folinate | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Calcium Folinate | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Capecitabin | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Capecitabin | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluorouracil | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fluorouracil | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Irinotecan | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Irinotecan | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Oxaliplatin | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Oxaliplatin | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tegafur | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Norwegian 2023-509814-12-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-509814-12-00 | 1.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-23 | Denmark | Acceptable 2023-12-08
|
2023-12-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-24 | Denmark | Acceptable 2024-06-17
|
2024-06-18 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-07-06 | Acceptable 2024-06-17
|
2024-09-23 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-03 | Acceptable | 2024-10-31 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-31 | Denmark | Acceptable 2024-11-07
|
2024-11-07 |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-03-30 | Acceptable 2024-11-07
|
2025-06-17 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-10 | Denmark | Acceptable 2026-01-13
|
2026-01-13 |