Comparing Palliative Radiotherapy With or Without Carboplatin (METAXIOM)

Phase-3 Study, Randomized, Controlled, Multi-center, Double Blind, Comparing Palliative Radiotherapy With or Without Carboplatin

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer; Lung Cancer; Metastatic Cancer
• Intervention / Treatment: Combination product: irradiation + carboplatin; Combination product: irradiation + placebo

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Le Mans, France, 72000
    • Fabrice Denis
  • Nantes, France
    • Institut de Cancérologie de l'Ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Combination product: irradiation + carboplatin; 30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin
Placebo Comparator: 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	Combination product: irradiation + placebo; 30 Gy en 10 fractions de 3 Gy + 10 injections of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: FABRICE DENIS, MD, Centre Jean Bernard

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2015
• Primary Completion (Actual): November 28, 2017
• Study Completion (Actual): May 28, 2018

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: carboplatin; placebo; irradiation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Neoplastic Processes; Head and Neck Neoplasms; Neoplasm Metastasis; Antineoplastic Agents; Carboplatin
• Other Study ID Numbers: ICO-A-2014-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No