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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

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 2016 Phase 2 trial • 175 Patients • NCT01055314
36%
Febrile neutropenia
31%
Death NOS
30%
Diarrhea
22%
Pain
21%
Hyperglycemia
16%
Anorexia
16%
Infections and infestations - Other, specify
16%
Alanine aminotransferase increased
14%
Hypokalemia
13%
Nausea
11%
Hyponatremia
10%
Weight loss
9%
Mucositis oral
9%
Anemia
9%
Vomiting
9%
Aspartate aminotransferase increased
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
Hypotension
6%
White blood cell decreased
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Typhlitis
5%
Anxiety
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Blood bilirubin increased
3%
Lymphocyte count decreased
3%
Syncope
3%
Wound infection
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Vulval infection
2%
Upper gastrointestinal hemorrhage
2%
Thromboembolic event
2%
Depressed level of consciousness
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Ascites
1%
Soft tissue infection
1%
Bone marrow hypocellular
1%
Gastrointestinal disorders - Other, specify
1%
Vasovagal reaction
1%
Hepatobiliary disorders - Other, specify
1%
Heart failure
1%
Penile pain
1%
Delirium
1%
Esophageal pain
1%
Anal mucositis
1%
Menorrhagia
1%
Sore throat
1%
Anaphylaxis
1%
Vascular disorders - Other, specify
1%
Anal hemorrhage
1%
Tracheitis
1%
Seizure
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

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
229 Previous Clinical Trials
306,044 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
127 Previous Clinical Trials
67,482 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
~94 spots leftby Sep 2025
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