- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03637335
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Le Mans, Frankrig, 72000
- Fabrice Denis
-
Nantes, Frankrig
- Institut de Cancérologie de l'Ouest
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
|
30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin
|
Placebo komparator: 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
|
30 Gy en 10 fractions de 3 Gy + 10 injections of placebo
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Local progression-free survival of chemo radiotherapy compared with placebo-associated radiotherapy
Tidsramme: 36 months
|
= delay between the start date of treatment and the date of the first event related to the treated location
|
36 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Impact in quality of life
Tidsramme: 25 months
|
Evaluate with questionnaire QLQ-C30 at inclusion, at the end of treatment and during the following
|
25 months
|
Variation in intensity of pain
Tidsramme: 25 months
|
Analogical visual scale (EVA)
|
25 months
|
evolution of dose of pain medication
Tidsramme: 25 months
|
variation of dosage of pain medication between inclusion and the end of radiotherapy (mg, number of caps, ...)
|
25 months
|
toxicity due to radiotherapy
Tidsramme: 25 months
|
Toxicity 4 weeks after radiotherapy with NCI-CTC-AE v4
|
25 months
|
overall survey
Tidsramme: 36 months
|
Time between inclusion and death
|
36 months
|
To evaluate free progression survival
Tidsramme: 36 months
|
Time between inclusion and first progression
|
36 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: FABRICE DENIS, MD, Centre Jean Bernard
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ICO-A-2014-11
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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