Comparing Palliative Radiotherapy With or Without Carboplatin
NCT ID: NCT03637335
Last Updated: 2018-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
26 participants
INTERVENTIONAL
2015-08-17
2018-05-28
Brief Summary
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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.
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Detailed Description
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Patients receive 10 injections of carboplatin (validated chemo-sensitizing molecule) or placebo (glucose) before 10 radiation sessions.
The overall duration is 14 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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irradiation + carboplatin
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 + carboplatin
30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin
irradiation + placebo
Radiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Placebo :10 injections 1h prior irradiation
irradiation + placebo
30 Gy en 10 fractions de 3 Gy + 10 injections of placebo
Interventions
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irradiation + carboplatin
30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin
irradiation + placebo
30 Gy en 10 fractions de 3 Gy + 10 injections of placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Institut Cancerologie de l'Ouest
OTHER
Responsible Party
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Principal Investigators
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FABRICE DENIS, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Jean Bernard
Locations
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Fabrice Denis
Le Mans, , France
Institut de Cancérologie de l'Ouest
Nantes, , France
Countries
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Other Identifiers
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ICO-A-2014-11
Identifier Type: -
Identifier Source: org_study_id
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