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

NCT04083365 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-05-31

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    collaborator OTHER

  • AUSL Romagna Rimini

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-11-30
Completion
2025-08-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04083365 on ClinicalTrials.gov