Comparing Palliative Radiotherapy With or Without Carboplatin

Phase 3

Terminated

• Conditions: Lung Cancer; Head and Neck Cancer; Metastatic Cancer
• Interventions: Combination Product: irradiation + carboplatin; Combination Product: irradiation + placebo

• Registration Number: NCT03637335
• Lead Sponsor: Institut Cancerologie de l'Ouest

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.

Study Timeline

• Study Start: 2015-08-17
• Primary Completion: 2017-11-28
• Study Completion: 2018-05-28
• Status Verified: 2018-07
• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-16
• Last Update Submitted: 2018-08-16
• Study First Posted: 2018-08-20
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
irradiation + carboplatin	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 + placebo	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
toxicity due to radiotherapy	25 months	Toxicity 4 weeks after radiotherapy with NCI-CTC-AE v4
Impact in quality of life	25 months	Evaluate with questionnaire QLQ-C30 at inclusion, at the end of treatment and during the following
To evaluate free progression survival	36 months	Time between inclusion and first progression
Variation in intensity of pain	25 months	Analogical visual scale (EVA)
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, ...)
overall survey	36 months	Time between inclusion and death

Trial Locations

Locations (2)

Fabrice Denis; 🇫🇷 Le Mans, France

Institut de Cancérologie de l'Ouest; 🇫🇷 Nantes, France