Induction Chemotherapy for MRF-negative, Moderate-risk, Resectable Middle and Low Rectal Cancer

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to test the Safety and efficacy of induction and individualized neoadjuvant chemotherapy based on oxaliplatin combined with fluorouracil for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Cancer Hospital
• Treatments: Antiemetics; Capecitabine; Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

• • Age ≥18 years and ≤80 years

• ECOG Performance status 0-1

• Histologically confirmed diagnosis of adenocarcinoma of the rectum

• The distance from down verge of tumor to anal-rectal junction (ARJ) ≤8cm based on MRI, or ≤12cm based on sigmoidoscopy;

• Clinical Stage based on MRI

1. mrMRF(-)

2. T3c/T3d/T4a, anyN, or T3bN+

• No evidence of distant metastases

• No prior pelvic radiation therapy

• No prior chemotherapy or surgery for rectal cancer

• No active infections requiring systemic antibiotic treatment

• ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.

• Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.

Exclusion Criteria:

• • Recurrent rectal cancer

• Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins.

• The pathological grade was Grade 4, i.e. mucus, signet ring or undifferentiated cancer.

• Creatinine level greater than 1.5 times the upper limit of normal.

• Patients who have received prior pelvic radiotherapy.

• Patients who are unable to undergo an MRI.

• Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.

• Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.

• Other Anticancer or Experimental Therapy.

• Women who are pregnant or breast-feeding.

• Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.