Comparing Palliative Radiotherapy With or Without Carboplatin

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer, Head and Neck Cancer, Metastatic Cancer

Intervention / Treatment
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* Combination Product: irradiation + carboplatin
* Combination Product: irradiation + placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with locally advanced or metastatic bronchial or head and neck cancer Patient require palliative radiotherapy Age ≥ 18 years PS ≤ 2 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 Refusal of participation or inability to issue informed consent Person deprived of liberty or adult under guardianship Minor patients, pregnant or lactating women Participation in other interventional study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase-3 study, randomized, controlled, multi-center, double blind
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: irradiation + carboplatin<br>Radiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Carboplatin. :10 injections 1h prior irradiation | Combination Product: irradiation + carboplatin<br>* 30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin<br>|
| Placebo Comparator: irradiation + placebo<br>Radiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Placebo :10 injections 1h prior irradiation | Combination Product: irradiation + placebo<br>* 30 Gy en 10 fractions de 3 Gy + 10 injections of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy | = delay between the start date of treatment and the date of the first event related to the treated location | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact in quality of life | Evaluate with questionnaire QLQ-C30 at inclusion, at the end of treatment and during the following | 25 months | 
| Variation in intensity of pain | Analogical visual scale (EVA) | 25 months | 
| evolution of dose of pain medication | variation of dosage of pain medication between inclusion and the end of radiotherapy (mg, number of caps, ...) | 25 months | 
| toxicity due to radiotherapy | Toxicity 4 weeks after radiotherapy with NCI-CTC-AE v4 | 25 months | 
| overall survey | Time between inclusion and death | 36 months | 
| To evaluate free progression survival | Time between inclusion and first progression | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irradiation, placebo, carboplatin