drugset / Trial / NCT02998385

Chemo-radiotherapy Versus Radiotherapy in the Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)

NCT02998385 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

A phase III, multicenter, randomized, open-label, french study comparing: * Arm A : Radiotherapy alone (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction) (IMRT or protontherapy) * Arm B: Radiotherapy (66 to 70 Gy; 5 fractions/week; 1fraction/day; 2 Gy/fraction; IMRT or protontherapy) + concomitant cisplatin 100 mg/m2 IV on day 1 - J22 - 43 (3 cycles)

Timeline

Start
2017-01-20
Primary completion
2030-02
Completion
2030-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous