NCT03637335

Comparing Palliative Radiotherapy With or Without Carboplatin

Phase-3 Study, Randomized, Controlled, Multi-center, Double Blind, Comparing Palliative Radiotherapy With or Without Carboplatin

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study population has locally advanced or metastatic bronchial or head and neck cancer. This study assesses the value of concomitant chemo/radiotherapy with carboplatin daily during metastatic radiotherapy versus radiotherapy alone. The realization of a systemic treatment during the radiotherapy could make it possible to obtain a benefit on the control of the evolution of the metastases and thus of the pains generated, as well as on the quality of life of the patients. In addition, a benefit in overall survival is possible.

Detailed description

The study population has locally advanced or metastatic bronchial or head and neck cancer. Patients receive 10 injections of carboplatin (validated chemo-sensitizing molecule) or placebo (glucose) before 10 radiation sessions. The overall duration is 14 days.

Conditions

• Lung Cancer
• Head and Neck Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	irradiation + carboplatin	30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin
COMBINATION_PRODUCT	irradiation + placebo	30 Gy en 10 fractions de 3 Gy + 10 injections of placebo

Timeline

• Start date: 2015-08-17
• Primary completion: 2017-11-28
• Completion: 2018-05-28
• First posted: 2018-08-20
• Last updated: 2018-08-20

Locations

2 sites across 1 country: France