Tailored Operative or Non-operative Management for Low-risk Rectal Cancer After Intensive Neoadjuvant Treatment

• Status: Completed
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to test the efficacy of tailored operative or non-operative management (NOM) for MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main purpose of this study is to increase organ-preservation rate for low-risk rectal cancer patients.

• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Age ≥18 years and ≤85 years

• ECOG Performance status 0-1

• Histologically confirmed diagnosis of adenocarcinoma of the rectum, with tumor differentiation Grade 1-3

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

• Clinical Stage T2 or T3a or T3b and EMVI (-) and MRF (-) and extra-mesorectal metastatic lymph node (-) 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

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

• 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 well treated basal cell cancer, squamous cell skin cancer, breast cancer, thyroid cancer or small renal cancer, and with DFS >5 years.

• 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.