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

Sponsor
AUSL Romagna Rimini
Study ID
NCT04083365
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 1, 2020
Status verified
May 2023
Primary completion
Nov 30, 2022
Completion
Aug 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CAPECITABINE + concomitant RT + Durvalumab
    After careful staging, patients will be initiated to a standard concomitant chemoradiation therapy with 825 mg/m2 twice daily capecitabine every day for 5 weeks and 5040 cGy radiotherapy for 5 days per week for 5 weeks. At the end of treatment patients will undergo a lesion biopsy. One week after the end of CT/RT patients will be treated with 1500 mg IV Q4W durvalumab for 3 administrations. From week 9 to 10 after neoadjuvant therapy will be performed re-staging with CT and MRI scan. Surgery will be performed at week 10-12 from the end of CT/RT and the surgical piece will be analyzed

Primary Outcome Measure

Pathological complete response (pCR) rate after durvalumab treatment [ Time Frame: 36 months ]

Central Contacts

Related Studies