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RECRUITING
NCT05496491
NA

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

Sponsor: Larissa University Hospital

View on ClinicalTrials.gov

Summary

The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2022-08-30

Completion Date

2026-08-30

Last Updated

2024-10-08

Healthy Volunteers

No

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

Locations (1)

Department of Surgery, University Hospital of Larissa

Larissa, Greece