Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs 5-FU/Leucovorin.

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

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the rectum

2. Patients who treated with preoperative chemoradiation with fluoropyrimidines followed by curative surgery without microscopic residual tumor.

3. AJCC/UICC pathologic stages of ypT3-4 or ypN+

4. Curative surgery not less than 3 and not more than 8 weeks prior to randomization

5. No prior chemotherapy, radiotherapy and immunotherapy except preoperative chemoradiation for rectal cancer

6. ECOG PS 0-1

7. Adequate organ function

8. Informed Consent

Exclusion Criteria:

1. Macroscopic or microscopic evidence of remaining tumor

2. Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease

3. More than 8 weeks after curative surgery