Comparing alternating oxaliplatin and irinotecan chemotherapy versus standard of care for metastatic colorectal cancer.

Phase 2

Recruiting

• Conditions: Metastatic Colorectal Cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12618001480279
• Lead Sponsor: The Walter and Eliza Hall Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-04
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Inclusion Criteria
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 Criteria

Exclusion Criteria
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine the feasibility of a multi-centre prospective registry-based randomised clinical trial evaluating alternating oxaliplatin and irinotecan doublet schedules vs. continuous doublet chemotherapy during initial treatment of metastatic colorectal cancer.<br>The primary feasibility endpoint will be evaluated by recruitment rate, defined as the proportion of eligible mCRC patients who enrol onto this study. [Eligible participants will be recruited over 1.5 years. All participants will be followed until death or study completion. ]