First-line mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab for Metastatic Left-sided CRC With Wild-type RAS/BRAF Genes

Launched by WEST CHINA HOSPITAL · Aug 23, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatment combinations for patients with metastatic left-sided colorectal cancer (CRC) who have specific genetic markers (wild-type RAS and BRAF genes). The study aims to compare the effectiveness and safety of two treatment options: one that uses capecitabine and oxaliplatin (mCapOX) alongside cetuximab, and the other that uses a combination of fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) with cetuximab. Both treatments are considered first-line therapies, meaning they are among the first options given to patients with this type of cancer.

To be eligible for the trial, participants need to be at least 18 years old and have a confirmed diagnosis of metastatic left-sided colorectal cancer. They also need to have at least one measurable cancer lesion and a good overall health status, as indicated by specific performance scores. Participants should not have received any previous first-line chemotherapy for their cancer and must meet certain health criteria related to their blood counts and organ function. If you join this study, you'll be closely monitored for your health and any side effects during the treatment process, contributing to important research that could help improve care for others with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able to provide written informed consent and can understand and comply with the requirements of the study;
• • Men and women ≥ 18 years of age;
• • Patients with histologically or cytologically confirmed metastatic left-sided colorectal adenocarcinoma with wild-type RAS and BRAF genes;
• • Presence of at least one evaluable lesion, as defined in RECIST Version 1.1;
• • With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
• • No palliative first-line chemotherapy, targeted, immunotherapy, or prior platinum-based adjuvant chemotherapy, relapse more than 12 months from the end of adjuvant chemotherapy;
• • According to the imaging findings and surgical assessment of initial unresectable, synchronous metastatic colorectal cancer, no serious complications of the primary tumor (obstruction, perforation, massive hemorrhage that cannot be treated in internal medicine, etc.) ;
• • Life expectancy of longer than 3 months ( clinical assessment);
• • Requirements for lab indicators neutrophils ≥ 1.5 × 109/L, platelets ≥ 75 × 109/L, hemoglobin ≥ 8 g/dL, total bilirubin ≤ 1.5 × upper limit of normal (UNL); ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases); alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases, ≤ 10 × UNL if bone metastases); LDH \< 1500 U/L; creatinine clearance (calculated according to Cockcroft and Gault formula) \> 50 mL/min or serum creatinine ≤ 1.5 × UNL;
• Exclusion Criteria:
• • Patients with mCRC who were initially resectable with R0 resection or radiofrequency or SBRT were excluded.
• • Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry
• • Hypersensitivity to any therapeutic agent.
• • Patients who received adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before entering the study;
• • Patients who have failed one or more palliative chemotherapy regimens;
• • Patients with uncontrolled hepatitis B virus
• • Peripheral neuropathy ≥ CTC grade 2;
• • Neurological or psychiatric disorders affecting cognitive performance;
• • Patients with central nervous system metastasis could not be controlled with radiotherapy;
• • Previous enteritis, chronic diarrhea, or recurrent bowel obstruction; uncontrolled bleeding from internal medicine; bowel perforation
• • Uncontrolled concomitant diseases within 6 months before the study, including unstable angina, acute myocardial infarction, cerebrovascular accident, etc.;
• • Pregnant or lactating patients, or those of childbearing potential who do not take adequate contraceptive measures;
• • History of other malignancies, but no disease-free survival longer than 5 years;
• • Patients concurrently receiving other anti-tumor treatment or participating in other interventional clinical trials;
• • Patients who are unable to comply with this study for psychological, family or social reasons.
• • Patients with other serious diseases that the investigator considers not suitable.