Clinical trial NCT03637335: Comparing Palliative Radiotherapy With or Without Carboplatin
Official title: Phase-3 Study, Randomized, Controlled, Multi-center, Double Blind, Comparing Palliative Radiotherapy With or Without Carboplatin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lung Cancer
Head and Neck Cancer
Metastatic Cancer
Keywords: irradiation
placebo
carboplatin
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase-3 study, randomized, controlled, multi-center, double blind
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy
timeFrame: 36 months
Secondary outcomes:
measure: Impact in quality of life
timeFrame: 25 months
measure: Variation in intensity of pain
timeFrame: 25 months
measure: evolution of dose of pain medication
timeFrame: 25 months
measure: toxicity due to radiotherapy
timeFrame: 25 months
measure: overall survey
timeFrame: 36 months
measure: To evaluate free progression survival
timeFrame: 36 months
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Fabrice Denis
city: Nantes
country: France
facility: Institut de Cancérologie de l'Ouest
Study officials:
affiliation: Centre Jean Bernard
name: FABRICE DENIS, MD
role: PRINCIPAL_INVESTIGATOR
References: