Head and Neck Cancer, Lung Cancer, Metastatic Cancer
Conditions
Keywords
irradiation, placebo, carboplatin
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.
Interventions
COMBINATION_PRODUCTirradiation + carboplatin
30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin
COMBINATION_PRODUCTirradiation + placebo
30 Gy en 10 fractions de 3 Gy + 10 injections of placebo
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Phase-3 study, randomized, controlled, multi-center, double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy | 36 months | = delay between the start date of treatment and the date of the first event related to the treated location |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact in quality of life | 25 months | Evaluate with questionnaire QLQ-C30 at inclusion, at the end of treatment and during the following |
| Variation in intensity of pain | 25 months | Analogical visual scale (EVA) from O (no pain) to 10 (worst pain) |
| evolution of dose of pain medication | 25 months | variation of dosage of pain medication between inclusion and the end of radiotherapy (mg, number of caps, ...) |
| toxicity due to radiotherapy | 25 months | Toxicity 4 weeks after radiotherapy with NCI-CTC-AE v4 |
| overall survey | 36 months | Time between inclusion and death |
| To evaluate free progression survival | 36 months | Time between inclusion and first progression |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFABRICE DENIS, MD
Centre Jean Bernard
Outcome results
None listed