Lung CancerPhase 3METAXIOMNCT03637335
Comparing Palliative Radiotherapy With or Without Carboplatin
A Phase 3 study testing irradiation + carboplatin in people with Lung Cancer and Head and Neck Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Head and Neck Cancer, Metastatic Cancer
- What is being tested?
- irradiation + carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Aug 2015to 28 May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Fabrice Denis
Le Mans, 72000
Institut de Cancérologie de l'Ouest
Nantes
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer, Head and Neck Cancer, Metastatic Cancer
- Being tested
- irradiation + carboplatin, irradiation + placebo
- Keywords
- irradiation, placebo, carboplatin
- Medical subject headings
- Lung Neoplasms, Head and Neck Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irradiation + carboplatinCombination product
30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin
irradiation + placeboCombination product
30 Gy en 10 fractions de 3 Gy + 10 injections of placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Combination Product: irradiation + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 months
Secondary outcomes (6)
Impact in quality of life
Evaluate with questionnaire QLQ-C30 at inclusion, at the end of treatment and during the following
Measured: 25 months
Variation in intensity of pain
Analogical visual scale (EVA) from O (no pain) to 10 (worst pain)
Measured: 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, ...)
Measured: 25 months
toxicity due to radiotherapy
Toxicity 4 weeks after radiotherapy with NCI-CTC-AE v4
Measured: 25 months
overall survey
Time between inclusion and death
Measured: 36 months
To evaluate free progression survival
Time between inclusion and first progression
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start17 Aug 2015
- Primary completion28 Nov 2017
- Study completion28 May 2018
Why it stopped: The study was stopped due to insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase-3 study, randomized, controlled, multi-center, double blind
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FABRICE DENIS, MD, Principal investigator, Centre Jean Bernard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637335
- Sponsor's protocol ID
- ICO-A-2014-11
- Acronym
- METAXIOM
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2018
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-3 Study, Randomized, Controlled, Multi-center, Double Blind, Comparing Palliative Radiotherapy With or Without Carboplatin
- ClinicalTrials.gov ID
- NCT03637335
- Acronym / sponsor ID
- METAXIOM / ICO-A-2014-11
- Conditions
- Lung Cancer, Head and Neck Cancer, Metastatic Cancer
- Keywords
- irradiation, placebo, carboplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to insufficient recruitment.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 17 Aug 2015 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 May 2018 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase-3 study, randomized, controlled, multi-center, double blind
| Arm | Type | Receives |
|---|---|---|
| irradiation + carboplatin | Experimental | Combination Product: irradiation + carboplatinRadiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Carboplatin. :10 injections 1h prior irradiation |
| irradiation + placebo | Placebo comparator | Combination Product: irradiation + placeboRadiotherapy in 30 Gy en 10 fractions de 3 Gy. The overall duration to irradiation is 2 weeks Placebo :10 injections 1h prior irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Other chemotherapy or targeted therapy
- Prior radiation
- Patients with thrombopenia < 100 000
- Patients with neutropenia < 2000
- Patients with renal clearance < 20 mL/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| irradiation + carboplatin30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin | Combination product | irradiation + carboplatin |
| irradiation + placebo30 Gy en 10 fractions de 3 Gy + 10 injections of placebo | Combination product | irradiation + placebo |
Primary outcome
Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy
Time frame: 36 months
= delay between the start date of treatment and the date of the first event related to the treated location
6 secondary outcomes
Impact in quality of life
Time frame: 25 months
Variation in intensity of pain
Time frame: 25 months
evolution of dose of pain medication
Time frame: 25 months
toxicity due to radiotherapy
Time frame: 25 months
overall survey
Time frame: 36 months
To evaluate free progression survival
Time frame: 36 months
Results and safety
The study was stopped early (reason given: The study was stopped due to insufficient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FABRICE DENIS, MD principal investigator
Centre Jean Bernard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing irradiation + carboplatin in people with Lung Cancer and Head and Neck Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to insufficient recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.