Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to receive an alternating schedule of oxiplatin based chemotherapy and irinotecan based chemotherapy, OR a chemotherapy that has been selected by the treating clinician.
All patients will receive combination chemotherapy for 4-6 months followed by a maintenance period.
Conditions
This trial is treating people with colorectal cancer
Eligibility
Inclusion
1. Signed informed consent obtained prior to any study specific procedures and willingness to comply with study requirements
2. Age greater than or equal to 18 years
3. Histologically confirmed, metastatic colorectal adenocarcinoma treated with less than or equal to 2 cycles of doublet chemotherapy
4. ECOG performance status of 0-2
5. Life expectancy of greater than or equal to 3 months
6. Adequate major organ function to receive doublet chemotherapy as judged by the treating clinician
7. No contraindication to any of the 3 cytotoxic agents (5FU, oxaliplatin and irinotecan)
8. Recent imaging of chest, abdomen and pelvis. It is recommended that this should be within 4 weeks of first chemotherapy dose (no more than 8 weeks).
Please note: Every patient enrolled in the study is then entered in the TRACC Registry to enable the data collection for the study.
Exclusion
1. Previous chemotherapy and/or biologic therapy for CRC, except for adjuvant treatment if completed more than 6 months earlier
2. Not suitable for doublet chemotherapy
3. Significant concomitant medical condition which the treating clinician believes precludes the patient from enrolling in the study
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Walter and Eliza Hall Institute
Scientific Title
Alternating oxaliplatin and irinotecan doublet schedules versus continuous doublet chemotherapy in previously untreated metastatic colorectal cancer: A Treatment of Recurrent and Advanced Colorectal Cancer registry-based prospective randomised trial
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