IROCAS : A Phase III, Randomised, international trial comparing mFOLFIRINOX triplet chemotherapy to mFOLFOX for highrisk stage III colon cancer in adjuvant setting

Conditions

High-risk stage III colon cancer

Brief summary

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.

Detailed description

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., 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., 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.

Related papers

No related papers found yet.

Interventions

DRUGOXALIPLATIN

DRUGFOLINIC ACID

DRUGIRINOTECAN

DRUGFLUOROURACIL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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., 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., 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.	—

Measure

Time frame

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., 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., 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.

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Countries

France, Italy

Outcome results

None listed