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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
26
30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin
30 Gy en 10 fractions de 3 Gy + 10 injections of placebo
Fabrice Denis
Le Mans, France
Institut de Cancérologie de l'Ouest
Nantes, France
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
Time frame: 36 months
Impact in quality of life
Evaluate with questionnaire QLQ-C30 at inclusion, at the end of treatment and during the following
Time frame: 25 months
Variation in intensity of pain
Analogical visual scale (EVA) from O (no pain) to 10 (worst pain)
Time frame: 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, ...)
Time frame: 25 months
toxicity due to radiotherapy
Toxicity 4 weeks after radiotherapy with NCI-CTC-AE v4
Time frame: 25 months
overall survey
Time between inclusion and death
Time frame: 36 months
To evaluate free progression survival
Time between inclusion and first progression
Time frame: 36 months
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