Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial

NARecruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

August 30, 2022

Primary Completion Date

August 30, 2026

Study Completion Date

August 30, 2026

Conditions
Rectal Neoplasms
Interventions
RADIATION

Neoadjuvant Chemoradiotherapy

5-week neoadjuvant radiotherapy regimen (28 x 1.8 Gy) combined with Capecitabine (bid 800 mg/m2, twice daily, on days 1-33-38)

DRUG

Adjuvant Chemotherapy

8 cycles of CAPOX (Capecitabine bid 1000 mg/m2, twice daily, day 1-14, every 3 weeks and Oxaliplatin 130 mg/m2, day 1, every 3 weeks) or alternatively, 12 cycles of folinate, fluorouracil and oxaliplatin (FOLFOX)

DRUG

Consolidation Chemotherapy

CAPOX (Capecitabine bid1000 mg/m2 and Oxaliplatin 130 mg/m2, day 1, every 3 weeks) or alternatively FOLFOX

Trial Locations (1)

41110

RECRUITING

Department of Surgery, University Hospital of Larissa, Larissa

All Listed Sponsors
lead

Larissa University Hospital

OTHER