NCT04083365

Capecitabine Plus Concomitant Radiation Therapy Followed by Durvalumab as Preoperative Treatment in Rectal Cancer

A Phase II Study of Capecitabine Plus Concomitant Radiotion Therapy Followed by Durvalumab (MEDI4736) as Preoperative Treatment in Rectal Cancer.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: AUSL Romagna Rimini · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective phase II, open label, single arm, multi-centre study to evaluate activity of an innovative sequence on capecitabine plus concomitant radiation therapy followed by durvalumab in patients with operable rectal cancer. The enrollment period will be of 12 months. Eligible patients will be initiated to a standard concomitant chemoradiation therapy for 5 weeks. One week after the end of CT/RT patients will be treated with durvalumab for 3 administrations. Patient will undergo surgery after 10-12 weeks from the end of CT/RT and the surgical piece will be analyzed. After surgery patients will be followed up for 5 years, according to clinical practice.

Conditions

• RECTAL CANCER

Interventions

Type	Name	Description
DRUG	Capecitabine	chemoradiation therapy with 825 mg/m2 twice daily capecitabine every day for 5 weeks
DRUG	Radiotherapy	5040 cGy radiotherapy for 5 days per week for 5 weeks
DRUG	Durvalumab	One week after the end of CT/RT patients will be treated with 1500 mg IV Q4W durvalumab for 3 administrations

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-11-30
• Completion: 2025-08-31
• First posted: 2019-09-10
• Last updated: 2023-05-31

Locations

1 site across 1 country: Italy