Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy for Rectal Cancer With MRI Negative CRM

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether primary radiotherapy can be omitted for the locally advanced rectal cancer with Magnetic Resonance Imaging (MRI) negative circumferential margin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Rectal adenocarcinoma or mucinous adenocarcinoma that is 12 cm or less from the anal verge.

• MRI scan confirmed cT3N0 or cT4aN0 or cT1-4aN+ mid rectal cancer (12-6cm from the anal verge) or cT1-2N+ low rectal cancer (5.9-0cm from the anal verge).

• MRI scan confirmed more than 1 mm circumferential margin.

• Age 18-75 years old.

• Without distant metastasis.

Exclusion Criteria:

• Malignant history.

• Contraindications of MRI scan.

• Contraindications of radiotherapy.

• Contraindications of chemotherapy.

• Pregnancy.

• Multidisciplinary team thinks that the patient is unsuitable to take part in research (For example, there are obvious regional lymph nodes involved in low rectal cancer patients who are thought with high risk of recurrence).

• Refuse to take part in research.