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ACTIVE NOT RECRUITING
NCT02998385
PHASE3

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

Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

View on ClinicalTrials.gov

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)

Official title: A Phase III Randomized Study of Chemo-radiotherapy Versus Radiotherapy Alone in the Adjuvant Treatment of Salivary Glands and Nasal Tumors (IMRT or Protontherapy)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

342

Start Date

2017-01-20

Completion Date

2030-03

Last Updated

2025-05-07

Healthy Volunteers

No

Conditions

Interventions

DRUG

Cisplatin

intravenous, concomitant to irradiation

RADIATION

radiotherapy

66 à 70 Gy per fractions of 2 Gy, 1 fraction/day, 5 fractions/week

Locations (1)

Hôpital Bégin

Saint-Mandé, France