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RecruitingLast updated: 9 September 2024

ALT-TRACC: This clinical trial is comparing alternating chemotherapy and standard of care for patients whose colorectal cancer has spread to other parts of the bodyAlternating 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

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 patients with colorectal cancer

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

II

Trial Acronym

ALT-TRACC

More information

Trial Identifiers

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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

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.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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