Comparing Palliative Radiotherapy With or Without Carboplatin

Lung Cancer Clinical Trial

— METAXIOM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03637335
• Other study ID #: ICO-A-2014-11
• Status: Terminated
• Phase: Phase 3
• Start date: August 17, 2015
• Est. completion date: May 28, 2018

Study information

• Verified date: July 2018
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: May 28, 2018
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Combination Product:
• 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

Locations

Country	Name	City	State
France	Fabrice Denis	Le Mans
France	Institut de Cancérologie de l'Ouest	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

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