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

NCT04230759 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-09-19

No results posted yet for this study

Summary

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).

Conditions

  • Anal Cancer
  • Anal Carcinoma
  • Anal Cancer Stage III
  • Anal Cancer Stage II

Interventions

DRUG

Chemotherapy

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

DRUG

Durvalumab

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

Sponsors & Collaborators

  • Goethe University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-07
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04230759 on ClinicalTrials.gov