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Comparing Palliative Radiotherapy With or Without Carboplatin (METAXIOM)

Primary Purpose

Lung Cancer, Head and Neck Cancer, Metastatic Cancer

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
irradiation + carboplatin
irradiation + placebo
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring irradiation, placebo, carboplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fabrice Denis
  • Institut de Cancérologie de l'Ouest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

irradiation + carboplatin

irradiation + placebo

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2018
Last Updated
August 16, 2018
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT03637335
Brief Title
Comparing Palliative Radiotherapy With or Without Carboplatin
Acronym
METAXIOM
Official Title
Phase-3 Study, Randomized, Controlled, Multi-center, Double Blind, Comparing Palliative Radiotherapy With or Without Carboplatin
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to insufficient recruitment.
Study Start Date
August 17, 2015 (Actual)
Primary Completion Date
November 28, 2017 (Actual)
Study Completion Date
May 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Head and Neck Cancer, Metastatic Cancer
Keywords
irradiation, placebo, carboplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase-3 study, randomized, controlled, multi-center, double blind
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
irradiation + carboplatin
Arm Type
Experimental
Arm 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
Arm Title
irradiation + placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Combination Product
Intervention Name(s)
irradiation + carboplatin
Intervention Description
30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin
Intervention Type
Combination Product
Intervention Name(s)
irradiation + placebo
Intervention Description
30 Gy en 10 fractions de 3 Gy + 10 injections of placebo
Primary Outcome Measure Information:
Title
Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy
Description
= delay between the start date of treatment and the date of the first event related to the treated location
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Impact in quality of life
Description
Evaluate with questionnaire QLQ-C30 at inclusion, at the end of treatment and during the following
Time Frame
25 months
Title
Variation in intensity of pain
Description
Analogical visual scale (EVA)
Time Frame
25 months
Title
evolution of dose of pain medication
Description
variation of dosage of pain medication between inclusion and the end of radiotherapy (mg, number of caps, ...)
Time Frame
25 months
Title
toxicity due to radiotherapy
Description
Toxicity 4 weeks after radiotherapy with NCI-CTC-AE v4
Time Frame
25 months
Title
overall survey
Description
Time between inclusion and death
Time Frame
36 months
Title
To evaluate free progression survival
Description
Time between inclusion and first progression
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FABRICE DENIS, MD
Organizational Affiliation
Centre Jean Bernard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fabrice Denis
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Nantes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing Palliative Radiotherapy With or Without Carboplatin

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