- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00535275
NSCLC Relapse Therapy After Surgery and Peri-operative Chemotherapy
Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
As chemotherapy gains wider acceptance for the treatment of earlier stages of NSCLC, particularly in the adjuvant and neoadjuvant setting, physicians face a growing population of high performance status patients who have relapsed after their first-line chemotherapy. The type of second-line chemotherapy after initial adjuvant or neoadjuvant treatment with a platinum-based regimen remains largely undefined. Some might consider rechallenging patients with a platinum based doublet whereas others might treat these patients with a monochemotherapy (pemetrexed or docetaxel).
Most relapses occurring after perioperative chemotherapy and surgery are non surgical locally advanced relapses or metastatic diseases.
Some differences exist between these post surgical relapses and the progressions occurring after the first line non surgical treatment of a stage III/IV.
- Patients are most often in a good condition (performance status 0-1).
- Progression is often asymptomatic and diagnosed in the post surgical follow up.
- The dose of chemotherapy previously administered is lower than that administered in first line of a stage III/IV.
- The time between the first line of treatment and the treatment of the relapse is longer.
These differences might be associated with a more chemosensitive disease and thus might be the rationale of using a platinum containing doublet instead of the classical mono chemotherapy docetaxel or pemetrexed.
Thus, the current study has been designed to answer these questions.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Aix En Provence, França
- Centre Hospitalier
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Ambilly, França, 74100
- Annemasse - CH
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Annecy, França, 74374
- Annecy - CH
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Auxerre, França, 89011
- Auxerre - CH
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Auxerre, França, 89000
- Auxerre - Polyclinique
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Bayonne, França
- CH de la Cote Basque
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Beauvais, França, 60021
- Beauvais - CH
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Besancon, França, 25000
- CHU Besancon - Pneumologie
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Blois, França, 41016
- Blois - CH
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Bobigny, França, 93000
- APHP - CHU Avicenne - Oncologie Medicale
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Boulogne, França
- Boulogne - Ambroise Paré
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Caen, França, 14000
- Caen - Centre François Baclesse
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Caen, França, 14000
- CHU - Pneumologie
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Calais, França, 62017
- Calais - CH
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Cannes, França
- CH de Cannes
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Chambray Les Tours, França, 37170
- Chambray Les Tours - Clinique Léonard de Vinci
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Chauny, França
- Chauny - CH
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Chevilly-Larue, França, 94669
- Chevilly-Larue - CH
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Cholet, França
- Hôpital de Cholet - Pneumologie
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Clamart, França, 92140
- Hôpital Percy-Armées - Pneumologie
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Clermont-Ferrand, França
- Hôpitral Gabriel Montpied - Pneumologie
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Colmar, França
- CH
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Créteil, França
- CHI Creteil
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Dax, França, 40107
- Dax - CH
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Dijon, França, 21079
- Dijon - CHU
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Epinal, França, 88021
- Epinal - CH
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Grenoble, França
- CHU
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Helfaut, França, 62570
- Saint Omer - CHI
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La Roche Sur Yon, França, 85925
- La Roche Sur Yon - CH
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Le Coudray, França, 28630
- Chartres - CH
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Le Mans, França, 72000
- Le Mans - Centre Hospitalier
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Limoges, França, 87042
- Limoges - Hôpital du Cluzeau
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Longjumeau, França
- CH de Longjumeau
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Lyon, França
- Hopital Louis Pradel
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Lyon, França, 69003
- Lyon - Clinique Mutualiste
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Lyon, França, 69000
- HCL - Croix-Rousse
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Macon, França
- CH de Macon
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Marseille, França
- Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
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Maubeuge, França, 59600
- Maubeuge - Polyclinique du Parc
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Meaux, França, 77100
- Meaux - CH
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Mont de Marsan, França, 40000
- Mont de Marsan - CH
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Montélimar, França
- Centre Hospitalier
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Moulins, França, 03000
- Moulins - CH
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Mulhouse, França, 68000
- Mulhouse - CH
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Nancy, França
- CHU
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Nanterre, França, 92014
- Nanterre - CH
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Nantes, França, 44805
- Nantes - Centre René Gauducheau
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Nevers, França
- CH Nevers
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Nîmes, França, 30900
- Nîmes - Clinique Valdegour
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Orléans, França, 45000
- Orléans - CH
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Paris, França
- Hopital Saint Antoine
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Paris, França, 75020
- APHP - Hopital Tenon - Pneumologie
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Paris, França
- GH Paris Saint-Joseph
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Perpignan, França, 66046
- Perpignan - Ch
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Perpignan, França, 66000
- Centre Catalan d'Onologie
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Pierre Bénite, França, 69495
- HCL - Lyon Sud (Pneumologie)
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Rambouillet, França
- Centre Hospitalier
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Reims, França, 51092
- Reims - CHU
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Reims, França
- Institut Jean Godinot
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Rodez, França, 12021
- Rodez - CH
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Roncq, França, 59223
- Roncq - Clinique Saint-Roch
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Roubaix, França, 59100
- Roubaix - CH
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Saint Nazaire, França, 44600
- Saint Nazaire - Centre Etienne Dolet
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Saint Quentin, França, 02100
- Saint Quentin - CH
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Saint-Brieuc, França
- CH de Saint-Brieuc
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Saint-Malo, França, 35403
- Saint-Malo - CH
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Saint-priest En Jarez, França, 42271
- Institut de Cancerologie de la Loire
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Strasbourg, França, 63000
- CHU Lyautey - Pneumologie
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Suresnes, França
- Hôpital Foch
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Thonon, França
- Hôpitaux du Léman - Pneumologie et Maladies Infectieuruses
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Toulon, França, 83000
- Toulon - CHI
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Toulouse, França
- Toulouse - CHU Larrey
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Tours, França, 37000
- Tours - CHU
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Troyes, França, 10000
- Troyes - CH
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Valenciennes, França, 59304
- Valenciennes - Clinique
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Vesoul, França
- CHI de la Haute-Saône - Pneumologie
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Vienne, França, 38200
- Vienne - CH
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Villejuif, França, 94800
- Institut Gustave Roussy
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients with histologically or cytologically confirmed inoperable non-small cell-lung cancer not eligible for curative radio-therapy (local or metastatic relapse).
- Previous history of adjuvant or neoadjuvant chemotherapy (at least 2 full cycles of a platinum containing regimen)
- Initial stage pT1N0 to pT3N2 (TNM classification 1999), complete resection. T4 tumours (several nodules in the same lobe) and M1 tumours (several nodules in the same lung) N0-2 completely resected are allowed to inclusion. Histological complete response tumours (pT0N0) after neoadjuvant chemotherapy are allowed to inclusion.
- At least one unidimensionally measurable disease (RECIST criteria) (lesions must have clearly defined margins on X-ray, CT-scan, MRI or ultra-sound (US) examination and should measure at least 1 cm if assessed by CT, MRI or US and at least 2 cm if assessed by X-ray, target lesions should be selected outside a previously irradiated field ). PET scans and ultra sonography are not allowed
- ECOG Performance status 0 to 1).
- Patients with adequate biological functions:
- Written informed consent from patient.
- The effects of docetaxel, cisplatin and carboplatin on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because docetaxel, cisplatin and carboplatin as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Life expectancy > 12 weeks
- Patient compliance and geographic proximity that allow adequate follow-up.
- Patient affiliated to a social insurance program
Exclusion Criteria:
- Previous treatment with docetaxel.
- Hypersensitivity to docetaxel, cisplatin, carboplatin or polysorbate 80 (excipient).
- Previous history of cancer other than Non small cell lung cancer, in situ carcinoma of the uterine cervix and basal cell carcinoma of the skin.
- Patients previously treated by an investigational agent in the last 30 days.
- Patient treated with preoperative platin based chemotherapy, achieving a progression of disease after treatment evaluation.
- Patients non responders to preoperative chemotherapy and whose tumor specimen did not disclose any necrosis nor tumoral modification thus confirming the lack of chemosensitivity to platin based chemotherapy
- Patient treated with platin based adjuvant chemotherapy, relapsing within the first 6 months after surgery.
- Patients with a peripheral neuropathy grade CTC >= 2
- Patients unable to fulfill protocol requirements
- Serious concomitant morbidity incompatible with the study (at the discretion of the investigator).
- Relapse within the month following lung cancer resection or adjuvant chemotherapy
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Significant loss of weight (> 10 %) in the 6 weeks preceding patient selection.
- Concomitant administration of another anti cancer treatment
- Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued.
- Patient under legal protection.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: UMA
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Docetaxel 75 mg/m² D1 + Cisplatine 75 mg/m² or Carboplatin AUC5 D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
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Comparador Ativo: B
Docetaxel monotherapy
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Docetaxel 75 mg/m² D1 (D1=D22, 4 cycles) Docetaxel 75 mg/m² D1 (D1=D22, 2 cycles if disease control)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
sobrevida livre de progressão (PFS)
Prazo: um ano
|
um ano
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Denis Moro-Sibilot, Pr, University Hospital, Grenoble
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IFCT-0702
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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