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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after inclusion
Awards & highlights
IROCAS Trial 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.Check my eligibility
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.See study design
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.
IROCAS Trial 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.
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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.
IROCAS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Free Survival (DFS)
Secondary outcome measures
Disease Free Survival
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Overall Survival
Side effects data
From 2016 Phase 2 trial • 175 Patients • NCT0105531436%
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%
Aspartate aminotransferase increased
9%
Anemia
9%
Mucositis oral
9%
Vomiting
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%
Anxiety
5%
Typhlitis
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%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
3%
Syncope
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Vulval infection
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%
Esophageal pain
1%
Gastrointestinal disorders - Other, specify
1%
Heart failure
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Vascular disorders - Other, specify
1%
Ascites
1%
Bone marrow hypocellular
1%
Anaphylaxis
1%
Delirium
1%
Sore throat
1%
Vasovagal reaction
1%
Anal hemorrhage
1%
Soft tissue infection
1%
Tracheitis
1%
Anal mucositis
1%
Seizure
1%
Menorrhagia
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)
IROCAS 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
Irinotecan
FDA approved
Fluorouracil
FDA approved
Find a Location
Who is running the clinical trial?
GONO GROUPUNKNOWN
UNICANCERLead Sponsor
221 Previous Clinical Trials
282,094 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
124 Previous Clinical Trials
66,661 Total Patients Enrolled
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:- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people currently being enrolled in this trial?
"The clinical trial is looking for participants and based on the information from clinicaltrials.gov, it appears that they are actively recruiting. The last date that this information was edited was on 8/2/2022 and the original posting date was 3/27/2017."
Answered by AI
Are there any dangerous side effects to the Folfox Protocol?
"Folfox Protocol has been deemed safe by our team, as it is a Phase 3 trial. This means that not only is there some data supporting efficacy, but multiple rounds of data confirm its safety."
Answered by AI
What type of cancer does the Folfox Protocol usually target?
"The Folfox Protocol is mostly used as a treatment for superficial basal cell carcinoma. However, it has also been successful in treating rectal carcinoma, colorectal carcinoma, and ovarian cancer."
Answered by AI
What are some other instances where the Folfox Protocol has been tested?
"Folfox Protocol is the focus of 639 ongoing clinical trials, 191 of which are in Phase 3. Though most investigations into Folfox Protocol are based out Guangzhou, Guangdong, there are actually 25550 research sites worldwide."
Answered by AI
Can adults of all ages participate in this research?
"The age limit for this trial is 75 years old, and participants must be of legal age in their jurisdiction."
Answered by AI
How can I become a subject in this experiment?
"This clinical trial is seeking 792 participants who meet the following criteria: - Cancer of the colon- Aged 18 to 75 years old - Must have an ECOG score of 0 or 1 if aged 71 to 75, and 2 or less if under 71 - Pathologically confirmed high-risk stage III colon adenocarcinoma restricted to pT4N1 or pT1-4N2 tumor. - Curative R0 surgical resection with no gross or microscopic evidence of residual disease after surgery. - Start of study drug treatment must be performed less than"
Answered by AI
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