Your session is about to expire
← Back to Search
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 belowSelect...
I have not had radiation therapy to my abdomen or pelvis.
Select...
My colon cancer is at a high-risk stage III.
Select...
I am between 18 and 75 years old.
Select...
I am between 18-70 years old with minimal activity restrictions or 71-74 and fully active.
Select...
I have never received chemotherapy.
Select...
I had surgery to remove all of my cancer.
Select...
I had surgery for colon cancer and no remaining cancer was found.
Select...
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:Select...
I have inflammatory bowel disease or a blockage in my intestines.
Select...
I haven't had major surgery or a serious injury in the last 28 days.
Select...
I have no or mild nerve damage or brain-related health issues.
Select...
I have a specific genetic condition and am not currently part of another drug trial.
Select...
I have serious heart disease or had a recent heart attack.
Select...
My cancer has spread to other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years after inclusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after inclusion
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 • NCT0325903578%
Fatigue
72%
Nausea
64%
Peripheral sensory neuropathy
55%
Diarrhea
41%
Constipation
41%
Anorexia
38%
Mucositis oral
34%
Paresthesia
33%
Rectal hemorrhage
28%
Dysesthesia
28%
Palmar-plantar erythrodysesthesia syndrome
22%
Vomiting
21%
Dyspnea
21%
Dysgeusia
19%
Abdominal pain
19%
Rectal pain
17%
Headache
17%
Pain in extremity
16%
Gastroesophageal reflux disease
16%
Rash maculo-papular
14%
Back pain
14%
Dry skin
14%
Dyspepsia
12%
Flatulence
10%
Insomnia
10%
Epistaxis
10%
Alopecia
10%
Facial pain
9%
Other gastrointestinal disorders
9%
Bloating
9%
Arthralgia
9%
Urinary retention
9%
Weight loss
9%
Fever
9%
Pain
7%
Arthritis
7%
Flushing
7%
Dysphagia
7%
Hoarseness
7%
Non-cardiac chest pain
7%
Dehydration
7%
Muscle cramp
7%
Dizziness
7%
Pruritus
7%
Hypertension
7%
Thromboembolic event
5%
Watering eyes
5%
Other musculoskeletal and connective tissue disorder
5%
Skin infection
5%
Laryngopharyngeal dysesthesia
5%
Generalized muscle weakness
5%
Muscle weakness lower limb
5%
Depression
5%
Hiccups
5%
Hypomagnesemia
5%
Urinary frequency
5%
Cough
5%
Erythema multiforme
5%
Other skin and subcutaneous tissue disorders
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
309,045 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
132 Previous Clinical Trials
69,075 Total Patients Enrolled
Jaafar BENNOUNA, ProfessorStudy ChairHôpital FOCH, SURESNES
Julien TAIEB, ProfessorStudy ChairHôpital Européen Georges-Pompidou, PARIS
Thierry ANDRE, ProfessorStudy ChairAP-HP Hôpital Saint-Antoine, PARIS
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major surgery or a serious injury in the last 28 days.I have no or mild nerve damage or brain-related health issues.I have not had radiation therapy to my abdomen or pelvis.I have inflammatory bowel disease or a blockage in my intestines.I haven't had cancer in the last 5 years, except for skin or cervical cancer that was completely treated.I have a specific genetic condition and am not currently part of another drug trial.My colon cancer is at a high-risk stage III.I am between 18 and 75 years old.I am between 18-70 years old with minimal activity restrictions or 71-74 and fully active.I have never received chemotherapy.I have serious heart disease or had a recent heart attack.I had surgery to remove all of my cancer.I had surgery for colon cancer and no remaining cancer was found.I will start the study drug within 56 days after my surgery.My cancer has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.