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Trial record 104 of 106 for:    Raynaud

Therapeutic Strategies in Patients With Non-squamous Non-small Cell Lung Cancer With Brain Metastases (METAL2)

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ClinicalTrials.gov Identifier: NCT02162537
Recruitment Status : Recruiting
First Posted : June 12, 2014
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Groupe Francais De Pneumo-Cancerologie
Information provided by (Responsible Party):
Isabelle MONNET, Centre Hospitalier Intercommunal Creteil

Brief Summary:

The patients carrying a complicated primary lung cancer brain metastases die in less than 3 months of delay disease in the absence of treatment. The median survival of these patients is approximately six months when the treatment associated with radiotherapy chemotherapy based on cisplatin is now the standard treatment. In most studies the patients die of their brain disease in one case only two, so it is likely that some patients do not require brain irradiation (prognosis in this case is linked to extra-cerebral disease ). The benefits for patients in group B (without systematic irradiation) are not to suffer the side effects of this radiation. The risks are in the same group to see brain metastases become symptomatic.

The role of cerebral radiotherapy in the patients treated with chemotherapy is unclear: should all patients be irradiated systematically (since the "reference" treatment is involved and with the aim of obtaining better control of the brain lesions and maintaining a better neurological status) or should only the patients showing cerebral progression be irradiated (avoidance of possibly useless brain radiotherapy and its side effects). The aim of this study is to better determine the position of cerebral radiotherapy in this context.

Main objective:

determine whether there is a difference in terms of progression-free survival between a therapeutic strategy with initial systematic brain radiotherapy followed by chemotherapy cis-platine/alimta + / - Bevacizumab and strategy with an initial chemotherapy cis-platine/alimta + / - Bevacizumab associated with brain radiotherapy only in cases of cerebral progression in patients with NSCLC with asymptomatic brain metastases


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Adenocarcinoma of Lung Metastatic to Brain Cerebral Metastases Drug: Cisplatin Drug: Pemetrexed Drug: Bevacizumab Radiation: Cerebral Radiotherapy Phase 3

Detailed Description:

This is a trial comparing two strategies with the aim to determine the best place for cerebral radiotherapy (initially or only systematic progression).

Arm A: Initial cerebral radiotherapy and chemotherapy, standard arm Arm B: Chemotherapy and Radiotherapy brain if clinical or radiological cerebral progression , experimental arm (The chemotherapy treatments are standard treatments using drugs with authorization in this indication)


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multicentric, Randomized, Phase III Trial Comparing 2 Strategies in Patients With Non-squamous Non-small Cell Lung Cancer With Asymptomatic Brain Metastases
Actual Study Start Date : December 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Arm A (standard arm)
Arm A: Initial Cerebral Radiotherapy and Chemotherapy (Cisplatin and pemetrexed with or without Bevacizumab)
Drug: Cisplatin
Cisplatin 75 mg/m2 IV (with adequate hydration) on D1 every 3 weeks.
Other Name: Cisplatine

Drug: Pemetrexed
500mg/m² IV(10 min. infusion, preceded by the usual folic acid, vitamin B12 and corticosteroid premedication)on D1 every 3 weeks
Other Name: Alimta

Drug: Bevacizumab
7.5 mg/kg on D1 every 3 weeks. In case of eligibility for Bevacizumab, the latter will not be started until C2.
Other Name: Avastin

Radiation: Cerebral Radiotherapy
Cerebral radiotherapy (encephalon in toto, 30 gy 10 sessions and 12 days) immediately after randomization before D1.If the number of brain metastases is less than or equal to 5 and less than or equal to 5 cm size, cerebral stereotactic radiotherapy condition may be proposed. The recommended interval between randomisation and D1 will be approximately 4 weeks.
Other Name: Brain Radiotherapy

Arm B (experimental arm)
Arm B: Chemotherapy (Cisplatin and pemetrexed with or without Bevacizumab) and Cerebral Radiotherapy if clinical or radiological progression brain
Drug: Cisplatin
Cisplatin 75 mg/m2 IV (with adequate hydration) on D1 every 3 weeks.
Other Name: Cisplatine

Drug: Pemetrexed
500mg/m² IV(10 min. infusion, preceded by the usual folic acid, vitamin B12 and corticosteroid premedication)on D1 every 3 weeks
Other Name: Alimta

Drug: Bevacizumab
7.5 mg/kg on D1 every 3 weeks. In case of eligibility for Bevacizumab, the latter will not be started until C2.
Other Name: Avastin

Radiation: Cerebral Radiotherapy
Cerebral radiotherapy (encephalon in toto, 30 gy 10 sessions and 12 days) immediately after randomization before D1.If the number of brain metastases is less than or equal to 5 and less than or equal to 5 cm size, cerebral stereotactic radiotherapy condition may be proposed. The recommended interval between randomisation and D1 will be approximately 4 weeks.
Other Name: Brain Radiotherapy




Primary Outcome Measures :
  1. To compare the progression-free survival rate in both arms [ Time Frame: From date of the randomization until the date of first detection of progression, or until the date of death, assessed up to up to approximately 90 months ]
    Whether there is a difference in terms of progression-free survival between a therapeutic strategy with initial brain radiotherapy followed by systematic chemotherapy with cis-platinum / alimta and a strategy with initial chemotherapy with cis-platinum / alimta with brain radiotherapy only if brain progression in patients with non-small cell lung cancer with brain metastases asymptomatic.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From the date of randomization until the date of patient death, assessed up to 90 months ]
    After 4 cycles of chemotherapy with platinum salt-pemetrexed (with or without bevacizumab) possibly followed, in case of control of the disease and if the patient's condition allows, by pemetrexed (alone or with bevacizumab if the latter was part of the initial treatment) as maintenance treatment until progression.

  2. Disease control rate (response + stability) [ Time Frame: Baseline, between 21 and 28 days, then every 6 weeks, up to approximately 24 months ]
    Repeat examinations to assess the measurable lesions or initials and examination necessary to confirm the appearance of a new lesion in case of clinical suspicion of disease progression (minimum CT scan and MRI).The radiological treatment response will be measured according to the RECIST 1.1 criteria

  3. Toxicity [ Time Frame: Every 3 weeks, up to approximately 24 months ]
    The safety of the induction combination of cisplatin or carboplatin plus pemetrexed (Alimta®) +/- bevacizumab, the maintenance treatment with pemetrexed (Alimta®) +/- bevacizumab and the pancerebral radiotherapy will be assessed based on the CTC toxicity criteria v3.0.

  4. Quality of life assessment [ Time Frame: Baseline, between 21 and 28 days, then every 6 weeks, up to approximately 24 months ]
    The quality of life assessment measurement will be performed by self-questionnaire. The EURO-QOL questionnaire will be used.

  5. Neurological assessment [ Time Frame: Baseline, between 21 and 28 days, then every 6 weeks, up to approximately 24 months ]
    The neurological assessment measurement will be performed by self-questionnaire. The MOCA questionnaires will be used.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically or cytologically proven non-epidermoid, non-small cell lung cancer, non-EGFR (Epidermal Growth Factor Receptor)-mutated (or mutation test impracticable).
  2. Patients with brain metastasis/metastases without neurosurgical indication.
  3. Asymptomatic patients (without treatment or with stable steroids or antiepileptic treatments for ≥ 5 days prior to obtaining the baseline MRI of the brain, and ≥ 5 days prior to first dose of study treatment (Cycle 1, Day 1).
  4. At least one lesion measurable according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
  5. ECOG (Eastern Cooperative Oncology Group) Performance Status 0 - 1
  6. No previous chemotherapy for this cancer, apart from adjunctive chemotherapy more than 18 months ago.
  7. Prior surgery is authorized in case of documented recurrence or progression.
  8. Adequate biological functions (hematologic, platelets, hemoglobin, hepatic function, alkaline phosphatases, ASAT (Aspartate transaminase) and ALAT (Alanine Aminotransferase); creatinine clearance).
  9. For women: Effective contraception for women of childbearing age during treatment and for 6 months following treatment.

    For men: They must be surgically sterile or accept the use of effective contraception until 6 months after the treatment period.

  10. Patients of more than 18 years of age.
  11. Estimated survival of at least 12 weeks.
  12. Consent signed by the patient

Exclusion Criteria:

  1. Patients presenting with a brain lesion eligible for curative treatment (neurosurgical).
  2. Symptomatic brain metastasis/metastases in spite of symptomatic treatment.
  3. Epidermoid carcinoma.
  4. Con indication of Bevacizumab is furthermore
  5. Patients presenting with a brain lesion eligible for curative treatment (neurosurgery or radiosurgery).
  6. Symptomatic brain metastasis/metastases in spite of symptomatic treatment.
  7. Epidermoid carcinoma.
  8. Cons indication of Bevacizumab
  9. Inability to take the folic acid or vitamin B12 vitamin supplementation or the dexamethasone premedication (or any equivalent corticosteroid), or any inability to comply with the study procedures.
  10. History of cancer, with the exception of cervical cancer in situ, skin cancer other than melanoma, adequately treated low-grade prostatic cancer (Gleason score <6), unless this cancer was diagnosed and treated more than 5 years ago without any signs of recurrence.
  11. Patients presenting with a systemic disorder which, in the investigator's opinion, compromises their participation in the study for reasons related to treatment safety or compliance.
  12. Patients incapable of discontinuing their aspirin treatment when the dose is > 1300 mg/day or their non-steroidal anti-inflammatory treatment two days before the day, on the day and two days the day of administration of pemetrexed (Alimta).
  13. Patients presenting with a 3rd sector (pleural effusion, ascites) which is clinically detectable and uncontrollable by simple measures of the evacuatory puncture type or other treatment before inclusion in the study.
  14. Patients presenting with neuropathy of grade > 2 according to the criteria of CTC (Common toxicity Criteria) v3.0.
  15. Patients whose foreseeable compliance or geographical distance renders monitoring difficult.
  16. Pregnant or breast-feeding women.
  17. Significant weight loss (≥ 10%) during the 6 weeks preceding inclusion in the study.
  18. Vaccination against yellow fever within 30 days preceding inclusion in the study.
  19. Cons-indication to taking steroids
  20. Persons deprived of their liberty as a result of a judicial or administrative decision
  21. Concomitant participation in another trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162537


Locations
France
Centre Hospitalier du Pays d'Aix Recruiting
Aix En Provence, France, 13613
Contact: Jacques LE TREUT       jletreut@ch-aix.fr   
Principal Investigator: Jacques LE TREUT         
Centre Hospitalier Victor Dupouy Recruiting
Argenteuil, France, 95100
Contact: Christine RAYNAUD       christine.raynaud@ch-argenteuil.fr   
Principal Investigator: Christine RAYNAUD         
Centre d'Oncologie et de Radiothérapie du Pays Basque Recruiting
Bayonne, France, 64100
Contact: Aurélien BLOUET       aurelien.blouet@oncologie-pays-basque.org   
Principal Investigator: Aurélien BLOUET         
Centre Hospitalier Recruiting
Beauvais, France, 60021
Contact: Jacky CREQUIT       Jacky.crequit@orange.fr   
Principal Investigator: Jacky CREQUIT         
Hôpital Avicenne Not yet recruiting
Bobigny, France, 93000
Contact: Antoine CARPENTIER       antoine.carpentier@avc.aphp.fr   
Principal Investigator: Antoine CARPENTIER         
HIA de Clermont-Tonnerre Not yet recruiting
Brest, France, 22240
Contact: Nicolas PALEIRON       nicolas.paleiron@free.fr   
Principal Investigator: Nicolas PALEIRON         
CHU Recruiting
Brest, France, 29200
Contact: Gilles ROBINET       gilles.robinet@chu-brest.fr   
Principal Investigator: Gilles ROBINET         
Centre François Baclesse Recruiting
Caen, France, 14000
Contact: Radj GERVAIS       r.gervais@baclesse.fr   
Principal Investigator: Radj GERVAIS         
Centre Hospitalier Recruiting
Charleville Meziere, France, 08000
Contact: Stéphane CHOUABE       Schouabe@ch-charleville-mezieres.fr   
Principal Investigator: Stéphane CHOUABE         
Centre Hospitalier Laennec Recruiting
Creil, France, 60109
Contact: Sandrine LOUTSKI-VETTESE       sandrine.loutski@ch-creil.fr.fr   
Principal Investigator: Sandrine LOUTSKI-VETTESE         
Centre Hospitalier Intercommunal Recruiting
Creteil, France, 94010
Contact: Isabelle MONNET       isabelle.monnet@chicreteil.fr   
Principal Investigator: Isabelle MONNET         
Centre Hospitalier Recruiting
Draguignan, France, 83300
Contact: Hervé LE CAER       herve.lecaer@ch-draguignan.fr   
Principal Investigator: Hervé LE CAER         
Centre Hospitalier Recruiting
GAP, France, 05000
Contact: Pascal THOMAS       pascal.thomas@chicas-gap.fr   
Principal Investigator: Pascal THOMAS         
Centre Hospitalier Robert Boulin Recruiting
Libourne, France, 33500
Contact: Samir ABDICHE       samir.abdiche@ch-libourne.fr   
Principal Investigator: Samir ABDICHE         
Hôpital Le Cluzeau Recruiting
Limoges, France, 87042
Contact: Alain VERGNENEGRE       avergne@unilim.fr   
Principal Investigator: Alain VERGNENEGRE         
Centre Hospitalier Régional Recruiting
Longjumeau, France, 91161
Contact: Gérard OLIVIERO       gerard.oliviero@ch-longjumeau.fr   
Principal Investigator: Gérard OLIVIERO         
Centre Hospitalier de Bretagne Sud Recruiting
Lorient, France, 56322
Contact: Régine LAMY       r.lamy@ch-bretagne-sud.fr   
Principal Investigator: Régine LAMY         
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Maurice PEROL       maurice.perol@lyon.unicancer.fr   
Principal Investigator: Maurice PEROL         
Centre Hospitalier Les Chanaux Recruiting
Macon, France, 71000
Contact: Dominique ARPIN       doarpin@ch-macon.fr   
Principal Investigator: Dominique ARPIN         
Centre Hospitalier F. QUESNAY Recruiting
Mantes La Jolie, France, 78200
Contact: Jean-Bernard AULIAC       j-b.auliac@ch-mantes-la-jolie.rss.fr   
Principal Investigator: Jean-Bernard AULIAC         
Institut Paoli Calmette Recruiting
Marseille, France, 13000
Contact: Anne MADROSZYC       madroszyca@marseille.fnclcc.fr   
Principal Investigator: Anne MADROSZYC         
Hôpital Nord APHM Recruiting
Marseille, France, 13915
Contact: Laurent GREILLIER       laurent.greillier@mail.ap-hm.fr   
Principal Investigator: Laurent GREILLIER         
Centre Hospitalier Recruiting
Meaux, France, 77108
Contact: Chrystèle LOCHER       ch-locher@ch-meaux.fr   
Principal Investigator: Chrystèle LOCHER         
Centre Hospitalier Intercommunal Recruiting
Meulan, France, 78250
Contact: Etienne LEROY-TERQUEM       etiennelt@hotmail.fr   
Principal Investigator: Etienne LEROY-TERQUEM         
Clinique du Pont de Chaume Recruiting
Montauban, France, 82000
Contact: Franck THOUVENY       fthouveny@clinique-pontdechaume.fr   
Principal Investigator: Franck THOUVENY         
Centre Hospitalier Recruiting
Perigueux, France, 24019
Contact: Jean-Yves DELHOUME       jy.delhoume@ch-perigeux.fr   
Principal Investigator: Jean-Yves DELHOUME         
Centre Catalan d'Oncologie Recruiting
Perpignan, France, 66000
Contact: Sabine VIEILLOT       sabinevieillot@gmail.com   
Principal Investigator: Sabine VIEILLOT         
Centre Hospitalier René Dubos Recruiting
Pontoise, France, 95303
Contact: Gislaine FRABOULET       gislaine.fraboulet@ch-pontoise.fr   
Principal Investigator: Gislaine FRABOULET         
Centre Hospitalier de la Région d'Annecy (CHRA) Recruiting
Pringy, France, 74374
Contact: Chantal DECROISETTE       cdecroisette@ch-annecy.fr   
Principal Investigator: Chantal DECROISETTE         
Centre Hospitalier Intercommunal de Cornouaille Recruiting
Quimper, France, 29107
Contact: Anne-Marie CHIAPPA       am.chiappa@ch-cornouaille.fr   
Principal Investigator: CHIAPPA Anne-Marie         
Hôpital Pontchailloux Recruiting
Rennes, France, 35033
Contact: Hervé LENA       herve.lena@chu-rennes.fr   
Principal Investigator: Hervé LENA         
Hôpital Charles Nicolle Recruiting
Rouen, France, 79031
Contact: Suzanna BOTA       Suzanna.bota@chu-rouen.fr   
Principal Investigator: Suzanna BOTA         
Clinique Mutualiste de l'Estuaire Recruiting
Saint Nazaire, France, 44600
Contact: Philippe DEGUIRAL       philippe.deguiral@mla.fr   
Principal Investigator: Philippe DEGUIRAL         
Institut de Cancérologie de la Loire (I.C.L) Recruiting
Saint Priest En Jarez, France, 42271
Contact: Pierre FOURNEL       pierre.fournel@icloire.fr   
Principal Investigator: Pierre FOURNEL         
Centre Hospitalier de Salon de Provence Recruiting
Salon de Provence, France, 13658
Contact: Jacques LE TREUT       jletreut@ch-aix.fr   
Principal Investigator: Jacques LE TREUT         
Centre Hospitalier Recruiting
Sens, France, 89108
Contact: GONZALEZ Gilles       ggonzalez@ch-sens.fr   
Principal Investigator: GONZALEZ Gilles         
Centre Paul Strauss Recruiting
Strasbourg, France, 67000
Contact: Roland SCHOTT       rschott@strasbourg.unicancer.fr   
Principal Investigator: Roland SCHOTT         
Hopital d'Instruction des Armées Sainte Anne Recruiting
Toulon, France, 83800
Contact: Henri BERARD       hberard@libertysurf.fr   
Principal Investigator: Henri BERARD         
Hôpital Larrey Recruiting
Toulouse, France, 31059
Contact: Laurence BIGAY-GAME       bigaygame.l@chu-toulouse.fr   
Principal Investigator: Laurence BIGAY-GAME         
Clinique Pasteur Recruiting
Toulouse, France, 31076
Contact: Olivier GALLOCHER       o.gallocher@clinique-pasteur.com   
Principal Investigator: Olivier GALLOCHER         
Centre Hospitalier Recruiting
Villefranche Sur Saone, France, 69655
Contact: Lionel FALCHERO       lfalchero@ch-villefranche.fr   
Principal Investigator: Lionel FALCHERO         
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Groupe Francais De Pneumo-Cancerologie
Investigators
Principal Investigator: Isabelle MONNET Centre Hospitalier Intercommunal Créteil

Responsible Party: Isabelle MONNET, Physician, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT02162537     History of Changes
Other Study ID Numbers: METAL 2
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Isabelle MONNET, Centre Hospitalier Intercommunal Creteil:
Strategy
Radiotherapy
Chemotherapy
Cisplatin

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Cisplatin
Bevacizumab
Pemetrexed
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors