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The study was stopped due to insufficient recruitment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| irradiation + carboplatin | Experimental | Radiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Carboplatin. :10 injections 1h prior irradiation |
|
| irradiation + placebo | Placebo Comparator | Radiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Placebo :10 injections 1h prior irradiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irradiation + carboplatin | Combination Product | 30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin |
|
| 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 |
| 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) from O (no pain) to 10 (worst pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| FABRICE DENIS, MD | Centre Jean Bernard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fabrice Denis | Le Mans | 72000 | France | |||
| Institut de Cancérologie de l'Ouest |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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Phase-3 study, randomized, controlled, multi-center, double blind
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| irradiation + placebo | Combination Product | 30 Gy en 10 fractions de 3 Gy + 10 injections of placebo |
|
| 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 |
| Nantes |
| France |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |