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Alkylating agents

Chemotherapy Combinations for Colon Cancer (IROCAS Trial)

Phase 3
Waitlist Available
Research Sponsored by UNICANCER
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function including 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, Creatinine clearance ≥50 mL/min, Kalemia, magnesemia, calcemia ≥ 1 LLN, CEA ≤10ng/mL after surgery, Adequate contraception if applicable, Able and willing to comply with study procedures, Able to understand and sign informed consent form, Public or private health insurance coverage, Life expectancy of > or = 5 years, Uracilemia < 16 ng/ml (only for French centers)
No prior abdominal or pelvic irradiation
Must not have
Presence of inflammatory bowel disease and/or ileus
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after inclusion
Awards & highlights
Pivotal Trial
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing two different chemotherapy combinations to see which is better at treating high-risk stage III colon cancer.

Who is the study for?
Adults aged 18-75 with high-risk stage III colon cancer who've had surgery for it, have good organ function, and no prior chemo or radiation. They must not have other significant diseases, a history of certain cancers within the last 5 years, or be in another drug trial. Pregnant women and those with central nervous system disease or peripheral neuropathy are excluded.
What is being tested?
The study compares two chemotherapy protocols for colon cancer after surgery: mFOLFIRINOX (a mix of irinotecan, oxaliplatin, folinic acid & fluorouracil) versus mFOLFOX6 (oxaliplatin with folinic acid & fluorouracil). It's to see which is better at preventing cancer from coming back.
What are the potential side effects?
Possible side effects include nausea, vomiting, diarrhea, fatigue, risk of infection due to low blood cell counts; nerve damage causing numbness or tingling; allergic reactions; heart problems like irregular heartbeat; and liver issues indicated by changes in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had radiation therapy to my abdomen or pelvis.
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My colon cancer is at a high-risk stage III.
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I am between 18 and 75 years old.
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I am between 18-70 years old with minimal activity restrictions or 71-74 and fully active.
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I have never received chemotherapy.
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I had surgery to remove all of my cancer.
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I had surgery for colon cancer and no remaining cancer was found.
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I will start the study drug within 56 days after my surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have inflammatory bowel disease or a blockage in my intestines.
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I haven't had major surgery or a serious injury in the last 28 days.
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I have no or mild nerve damage or brain-related health issues.
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I have a specific genetic condition and am not currently part of another drug trial.
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I have serious heart disease or had a recent heart attack.
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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after inclusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after inclusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Free Survival (DFS)
Secondary study objectives
Disease Free Survival
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Overall Survival

Side effects data

From 2024 Phase 2 trial • 58 Patients • NCT03259035
78%
Fatigue
72%
Nausea
64%
Peripheral sensory neuropathy
55%
Diarrhea
41%
Anorexia
41%
Constipation
38%
Mucositis oral
34%
Paresthesia
33%
Rectal hemorrhage
28%
Dysesthesia
28%
Palmar-plantar erythrodysesthesia syndrome
22%
Vomiting
21%
Dysgeusia
21%
Dyspnea
19%
Rectal pain
19%
Abdominal pain
17%
Headache
17%
Pain in extremity
16%
Gastroesophageal reflux disease
16%
Rash maculo-papular
14%
Dry skin
14%
Back pain
14%
Dyspepsia
12%
Flatulence
10%
Facial pain
10%
Epistaxis
10%
Insomnia
10%
Alopecia
9%
Bloating
9%
Weight loss
9%
Pain
9%
Fever
9%
Arthralgia
9%
Other gastrointestinal disorders
9%
Urinary retention
7%
Pruritus
7%
Arthritis
7%
Thromboembolic event
7%
Dysphagia
7%
Dehydration
7%
Non-cardiac chest pain
7%
Hoarseness
7%
Flushing
7%
Hypertension
7%
Muscle cramp
7%
Dizziness
5%
Hiccups
5%
Laryngopharyngeal dysesthesia
5%
Skin infection
5%
Generalized muscle weakness
5%
Erythema multiforme
5%
Muscle weakness lower limb
5%
Urinary frequency
5%
Hypomagnesemia
5%
Other skin and subcutaneous tissue disorders
5%
Depression
5%
Cough
5%
Other musculoskeletal and connective tissue disorder
5%
Watering eyes
2%
Laryngeal edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy (FOLFOX or CAPOX) Followed by Tumour Excision

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment2 Interventions
mFOLFIRINOX Folfox Protocol + Irinotecan
Group II: Arm BActive Control1 Intervention
mFOLFOX 6 Folfox Protocol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Irinotecan
FDA approved

Find a Location

Who is running the clinical trial?

GONO GROUPUNKNOWN
UNICANCERLead Sponsor
233 Previous Clinical Trials
309,234 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
132 Previous Clinical Trials
69,075 Total Patients Enrolled

Media Library

Irinotecan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02967289 — Phase 3
Colon Cancer Research Study Groups: Arm A, Arm B
Colon Cancer Clinical Trial 2023: Irinotecan Highlights & Side Effects. Trial Name: NCT02967289 — Phase 3
Irinotecan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02967289 — Phase 3
~48 spots leftby Jun 2025
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