NCT03637335

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_3 lung-cancer

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

August 6, 2018

Last Update Submit

June 5, 2026

Conditions

Metastatic CancerLung CancerHead and Neck Cancer

Keywords

irradiationplacebocarboplatin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Impact in quality of life

    25 months

  • Variation in intensity of pain

    25 months

  • evolution of dose of pain medication

    25 months

  • toxicity due to radiotherapy

    25 months

  • overall survey

    36 months

  • +1 more secondary outcomes

Study Arms (2)

irradiation + carboplatin

EXPERIMENTAL

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

irradiation + placebo

PLACEBO COMPARATOR

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

Interventions

irradiation + carboplatinCOMBINATION_PRODUCT

30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin

irradiation + carboplatin
irradiation + placeboCOMBINATION_PRODUCT

30 Gy en 10 fractions de 3 Gy + 10 injections of placebo

irradiation + placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fabrice Denis

Le Mans, 72000, France

Location

Institut de Cancérologie de l'Ouest

Nantes, France

Location

MeSH Terms

Conditions

Lung NeoplasmsHead and Neck NeoplasmsNeoplasm Metastasis

Interventions

RadiationCarboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical PhenomenaCoordination ComplexesOrganic Chemicals

Study Officials

  • FABRICE DENIS, MD

    Centre Jean Bernard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase-3 study, randomized, controlled, multi-center, double blind
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 20, 2018

Study Start

August 17, 2015

Primary Completion

November 28, 2017

Study Completion

May 28, 2018

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)