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

Sponsor
Goethe University
Study ID
NCT04230759
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Chemotherapy — DRUG
    Patients receive chemotherapy cycles as followed: Mitomycin-C 12 mg/m², day 1 (maximum single dose 20 mg) 5-FU: 1000 mg/m² per day, continuous i.v. infusion, on day 1-4 and 29-32
  • Radiation — RADIATION
    PTV\_A (primary tumor): T1-T2\<4cm N+: 28 x 1.9 Gy=53.2 Gy, five fractions per week or PTV\_A (primary tumor): T2\>=4cm, T3-4 Nany: 31 x 1.9 Gy=58.9 Gy, five fractions per week PTV\_N (involved node): 28 x 1.8 Gy=50.4 Gy, five fractions per weeks PTV\_Elec (elective node): 28 x 1.43 Gy=40.0 Gy, five fractions per week
  • Durvalumab — DRUG
    1500 mg, 1h-civ, every 4 weeks (q4w) applied on day -14 (that is 14 days prior to initiation of RCT), day 15 (during RCT), and thereafter q4w (+/- 3d) for a total of 12 doses

Study Details

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).

Key Dates

Start date
Jan 7, 2020
Status verified
Sep 2024
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

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

Arms

  • Active Comparator: 5FU+Mitomycin C
    Radiochemotherapy for anal cancer
  • Experimental: 5FU+Mitomycin C+Durvalumab
    Radiochemotherapy with Durvalumab for anal cancer

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: 3 years ]

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