Capecitabine Plus Concomitant Radiation Therapy Followed by Durvalumab as Preoperative Treatment in Rectal Cancer
Status:
Recruiting
Trial end date:
2025-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
AUSL ROMAGNA AUSL Romagna Rimini
Collaborators:
AstraZeneca Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori