Trial intelligence / Profile preview

RADIANCE: Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma

NCT04230759Phase 2

Key facts

Status
Active, not recruiting
Start
Jan 2020
Primary completion
Dec 2026
Countries
3
Sponsor
Goethe University Frankfurt
Modality
Antibody Conjugates, Engineered Antibody Formats, PD-1/PD-L1 Inhibitors
Conditions
anal squamous cell carcinoma (SCCA)
01

Overview

Phase 2, randomised trial of durvalumab in anal squamous cell carcinoma (SCCA) (2 arms), sponsored by Goethe University Frankfurt. Primary endpoint: Disease-Free Survival at 3 years. Started Jan 2020; status: active, not recruiting.

02

Design

2 arms
Study design
Randomized
  • 5FU+Mitomycin C

    Standard radiochemotherapy (5-FU + Mitomycin C + Radiation)

  • 5FU+Mitomycin C+Durvalumab

    Standard radiochemotherapy + Durvalumab

03

Who it enrols

Adult patients with locally-advanced (Stage IIB-IIIC) anal squamous cell carcinoma, ECOG 0-1, adequate organ function, and no prior treatment with PD-1/PD-L1 inhibitors.

04

Endpoints

Primary

  • Disease-Free Survival

Secondary

  • Major Adverse Events

  • Clinical Complete Response

  • Overall Survival

  • Colostomy-Free Survival

  • Cumulative Incidence of Locoregional Recurrence

  • Cumulative Incidence of Distant Recurrence

  • Quality of Life

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