Total Neoadjuvant Induction and Consolidation CapeOX Plus IMRT With Capecitabine for MRI Defined High-risk Rectal Cancer

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to test the efficacy and safety of total neoadjuvant induction and consolidation CapeOX plus neoadjuvant intensity modulated radiotherapy with concurrent capecitabine for MRI defined high-risk rectal cancer.

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

Details

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

Criteria

Inclusion Criteria:

• Age ≥ 18 years and ≤75 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 ≤12 cm based on sigmoidoscopy.

• Clinical Stage T3c, T3d, T4a or T4b, or EMVI (+) or mrN2 or CRM (+) based on MRI.

• 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.

• Anticipated unresectable tumor after neoadjuvant treatment.

• 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.