RecruitingPhase 3NCT06226857

Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer

Predictive Value of Other Oncogene Mutations for Anti-EGFR Monoclonal Antibodies Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer: Multicenter Randomized Phase III Trial

Sponsor

City Clinical Oncology Hospital No 1

Enrollment

355 participants

Start Date

Jan 17, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal Neoplasms Chemotherapy Effect Molecular Sequence Variation

Summary

Patients meeting the inclusion criteria will be randomized 1:1 into Cohort A (n ≈ 177) or Cohort BC (n ≈ 177). Cohort A is the control: patients receive combination chemotherapy with FOLFOX plus anti-EGFR therapy (panitumumab or cetuximab) based on RAS/BRAF wild-type data, according to clinical guidelines. The BC cohort begins FOLFOX chemotherapy and simultaneously undergoes extensive molecular genetic profiling. Further, the BC cohort, depending on the profile, is divided into cohort B - patients without changes in alternative oncogenes, and cohort C - with changes in alternative oncogenes. The expected cohort ratio is 3:1 (\~120 and \~40 patients). Cohort B begins to receive anti-EGFR therapy in addition to chemotherapy, and the potentially resistant cohort C continues to receive chemotherapy alone or begins to receive bevacizumab if there are no contraindications.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether certain genetic mutations in colorectal cancer tumors affect how well patients respond to a class of drugs called anti-EGFR therapy. It focuses on patients with a specific type of metastatic colorectal cancer. **You may be eligible if...** - You are 18 or older with confirmed metastatic colorectal cancer that cannot be surgically removed - Your cancer started on the left side of the colon (from the splenic flexure onward) - Your tumor has tested negative for KRAS and NRAS mutations (called "wild type") - You have not yet received any treatment for the metastatic stage of your cancer - You are in reasonably good physical condition **You may NOT be eligible if...** - You have previously received systemic treatment for metastatic disease (recent adjuvant therapy may be acceptable) - Your organ function does not meet required thresholds - You do not have adequate blood counts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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