Phase-3 Study, Randomized, Controlled, Multi-center, Double Blind, Comparing Palliative Radiotherapy With or Without Carboplatin
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Institut Cancerologie de l'Ouest
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with locally advanced or metastatic bronchial or head and neck cancer
- •Patient require palliative radiotherapy
- •Age ≥ 18 years
- •Obtaining the signed written consent of the patient
- •Patient affiliated to a social security scheme
Exclusion Criteria
- •Other chemotherapy or targeted therapy
- •Prior radiation
- •Patients with thrombopenia \< 100 000
- •Patients with neutropenia \< 2000
- •Patients with renal clearance \< 20 mL/min
- •Known hypersensitivity to platinum salt
- •Treatment with phenytoin or fosphenytoin
- •In previous three months, a vaccination against yellow fever, live vaccin or live attenuated vaccine
- •Unchecked diabetes
- •hemorrhagic tumor
Outcomes
Primary Outcomes
Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy
Time Frame: 36 months
= delay between the start date of treatment and the date of the first event related to the treated location
Secondary Outcomes
- toxicity due to radiotherapy(25 months)
- Impact in quality of life(25 months)
- To evaluate free progression survival(36 months)
- Variation in intensity of pain(25 months)
- evolution of dose of pain medication(25 months)
- overall survey(36 months)