IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Unicancer, Unicancer

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

27 Mar 2017 → ongoing

Decision date (initial)

2024-10-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-517489-41-00

EudraCT number

2016-001491-29

ClinicalTrials.gov

NCT02967289

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective is the 3-year Disease Free Survival rate.

Secondary objectives 3

1. Evaluation of Efficacy: Disease-free-Survival at 2 years.
2. Overall Survival (OS)
3. Evaluation of Toxicity

Conditions and MedDRA coding

High-risk stage III colon cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

1. Patient ≥18 years and < 75 years
2. Patient ≥18 years and <71 years must have an ECOG ≤1 – Patients ≥71 years and < 75 years must have an ECOG = 0
3. Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor.
4. Curative R0 surgical resection.
5. Patients who have undergone surgery for colon cancer, defined as a tumor location >12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum), without gross or microscopic evidence of residual disease after surgery with curative intent
6. Start of study drug treatment has to be performed less than 56 days after surgery.
7. No prior chemotherapy.
8. No prior abdominal or pelvic irradiation.
9. Patient with adequate organ function: - Absolute neutrophil count (ANC) ≥ 2 x 109/L - Haemoglobin ≥9 g/dL - Platelets (PTL) ≥100 x 109/L - AST/ALT ≤2.5 x ULN - Alkaline phosphatase ≤2.5 x ULN - Total Bilirubin ≤1.5 x ULN (Upper Limit of Normal) - Creatinine clearance ≥50 mL/min (Cockcroft and Gault formula) - Kalemia, magnesemia, calcemia ≥ 1 LLN (Lower Limit of Normal) - Carcinoembryogenic antigen (CEA) ≤10ng/mL after surgery (during screening period)
10. Adequate contraception if applicable.
11. Patient able and willing to comply with study procedures as per protocol
12. Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures
13. Public or private health insurance coverage
14. Life expectancy of > or = at 5 years
15. Uracilemia < 16 ng/ml (only for french centers)

Exclusion criteria 12

1. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study
2. Metastatic disease
3. Presence of inflammatory bowel disease and/or ileus
4. Known hypersensitivity reaction to any of the components of study treatments.
5. Pregnancy (absence to be confirmed by β-hCG test) or breast-feeding period
6. Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for women: QTc ≥470 msec)
7. Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
8. Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
9. History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v4.03.
10. Any significant disease which, in the investigator’s opinion, would exclude the patient from the study.
11. Patient with a DPD deficiency or UGT1A1 homozygous 7/7; the test should be done for all patients before 5-FU administration, according to ANSM communication regarding recommendation about high risk of no testing DPD in patient before 5-FU administration;
12. Patients already included in another therapeutic trial involving an experimental drug

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary end-point is the Disease Free Survival (DFS) at 3 years, defined as the time from the date of randomization up to the date of: - first local, regional or distant relapse; - second colorectal cancer; - death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored.

Secondary endpoints 3

1. Evaluation of Efficacy: The evaluation of efficacy is defined as the Disease Free Survival at 2 years, defined as the time from the date of randomization up to the date of: - first local, regional or distant relapse - second colorectal cancer - death from any cause included treatment-related death. Other primary cancer (except second primary colorectal) will be ignored.
2. Overall Survival (OS): Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause.
3. Evaluation of Toxicity: Safety of the study treatment will be assessed on occurrence of Adverse Events (AEs), intake of concomitant treatments, per-treatment arising changes in physical examination, vital signs (blood pressure, pulse rate and body temperature), ECG, and clinical laboratory tests (biochemistry, haematology). Safety parameters will be graded based on NCI CTCAE v4.03 classification.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Unicancer

Sponsor organisation

Unicancer

Address

101 Rue De Tolbiac

City

Paris

Postcode

75013

Country

France

Scientific contact point

Organisation

Unicancer

Contact name

Nourredine AIT RAHMOUNE

Public contact point

Organisation

Unicancer

Contact name

Nourredine AIT RAHMOUNE

Unicancer

Sponsor organisation

Unicancer

Address

101 Rue De Tolbiac

City

Paris Cedex 13

Postcode

75654

Country

France

Locations

2 EU/EEA countries · 79 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications