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Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group

Study acronym: RADIANCE
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study Identification, Study Status, Oversightv11
  2. Site details revised at 18 of 25 sitesv10
  3. Primary completion date: Mar 31, 2024 to Dec 31, 2026 Study sites: 26 to 25 · Completion date: Jun 30, 2026 to Mar 31, 2027v9 Show 2 more changesShow less
    • Study sites: 26 to 25
    • Completion date: Jun 30, 2026 to Mar 31, 2027
  4. Primary completion date: Mar 31, 2023 to Mar 31, 2024 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 178 to confirmed 180 · Study sites: 24 to 26 · 1 morev8 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 178 to confirmed 180
    • Study sites: 24 to 26
    • Start date: Jan 15, 2020 to Jan 7, 2020
  5. Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 1 of 24 sitesv6
  2. Study sites: 21 to 24v5
  3. Re-verified, no change to tracked fieldsv4
  4. Study sites: 20 to 21 Eligibility criteria shortened, about 36 wordsv3 Show 1 more changeShow less
    • Eligibility criteria shortened, about 36 words

    See this version in full on ClinicalTrials.gov ↗

  5. Interventions: Chemotherapy (Drug), PD-L1 (Drug), Radiation (Radiation) to Chemotherapy (Drug), Durvalumab (Drug), Radiation (Radiation) Study description shortened, about 135 wordsv2 Show 1 more changeShow less
    • Study description shortened, about 135 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The RADIANCE multicenter, randomized phase II trial will assess the efficacy of durvalumab, a PD-L1 immune checkpoint inhibitor, in combination with primary mitomycin C (MMC)/5-fluorouracil (5-FU)-based radiochemotherapy (RCT) in patients with locally-advanced anal squamous cell carcinoma (ASCC).
Trial Details
NCT Number NCT04230759
Lead Sponsor Goethe University
Conditions Anal Cancer, Anal Carcinoma, Anal Cancer Stage III, Anal Cancer Stage II
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov