ALT-TRACC

Protocol 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

Purpose of the Study

The purpose of this study is to determine the efficacy of alternating oxaliplatin and irinotecan doublet schedules versus continuous doublet chemotherapy in previously untreated metastatic colorectal cancer.

ELIGIBILITY CRITERIA

Inclusion Criteria

• Signed informed consent obtained prior to any study specific procedures and willingness to comply with study requirements
• Age ≥18 years
• Histologically confirmed, metastatic colorectal adenocarcinoma treated with ≤ 2 cycles of doublet chemotherapy
• ECOG performance status of 0-2
• Life expectancy of ≥3 months
• Adequate major organ function to receive doublet chemotherapy as judged by the treating clinician
• Recent imaging of chest, abdomen and pelvis.

Exclusion Criteria

• Previous chemotherapy and/or biologic therapy for CRC, except (A) adjuvant treatment if completed more than 6 months earlier or (B) initial chemoradiation with single agent fluoropyrimidine for patients initially presenting with metastatic rectal cancer
• Not suitable for doublet chemotherapy
• Significant concomitant medical condition which the treating clinician believes precludes the patient from enrolling in the study

Contact Email

Mr Michael Harold – michael.harold@mh.org.au or Dr Vanessa Wong – wong.v@wehi.edu.au

Study Chairs

Dr Vanessa Wong
Prof Peter Gibbs

DETAILED INFORMATION AVAILABLE

More detailed information available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here.

Funding

Victorian Comprehensive Cancer Centre