Comparing Palliative Radiotherapy With or Without Carboplatin (METAXIOM)

Institut Cancerologie de l'Ouest

Status and phase: Terminated; Phase 3

Conditions: Metastatic Cancer; Lung Cancer; Head and Neck Cancer

Treatments: Combination Product: irradiation + placebo; Combination Product: irradiation + carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03637335

ICO-A-2014-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

irradiation + carboplatin

Experimental group

Description:

Radiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Carboplatin. :10 injections 1h prior irradiation

Treatment:

Combination Product: irradiation + carboplatin

irradiation + placebo

Placebo Comparator group

Description:

Radiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Placebo :10 injections 1h prior irradiation

Treatment:

Combination Product: irradiation + placebo