Safety and Efficacy of Atezolizumab Combined to Preoperative Radio-chemotherapy in Localized Rectal Cancer

Sponsor
Grand Hôpital de Charleroi
Study ID
NCT03127007
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Rectal Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab is given on day 1 of week 3, 6, 9 and 12 at 1200 mg IV.
  • 5-FU based radio-chemotherapy — DRUG
    IV protracted 5-FU given at 225mg/m2 over 24h 5 days/week for 5 weeks associated to radiotherapy.

Study Details

The study has a phase Ib and a phase II part. The phase Ib part of the study aims to determine the safety and tolerance of administration at a fixed dosing of 1200 mg / 3 weeks, concomitantly to the standard preoperative radio-chemotherapy. The phase II part of the study aims to explore efficacy of atezolizumab in combination with the standard preoperative chemo/radiotherapy in stage II and III rectal cancers.

Key Dates

Start date
Apr 27, 2017
Status verified
Jan 2025
Primary completion
Feb 22, 2024
Completion
Oct 15, 2024

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Protracted IV 5-FU 225 mg/m2 is given from day 1 to 5 in parallel with radiotherapy 1.8 to 2 Gy from day 1 to 5 during 5 consecutive weeks. Atezolizumab is given on day 1 of week 3, 6, 9 and 12 at 1200 mg IV. Rectal surgery is planned during week 15
  • Active Comparator: Arm B
    Protracted IV 5-FU 225 mg/m2 is given from day 1 to 5 in parallel with radiotherapy 1.8 to 2 Gy from day 1 to 5 during 5 consecutive weeks. Rectal surgery is planned during week 15

Primary Outcome Measure

Rate of adverse events [ Time Frame: 74 weeks ]

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