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A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer (INOVA)

31 de julho de 2017 atualizado por: Hoffmann-La Roche

Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in Locally Advanced Resectable Rectal Cancer: A Randomized, Non-Comparative Phase II Study

This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

91

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • França
      • Angers, França, 49055
        • ICO Paul Papin; Oncologie Medicale.
      • Angers, França, 49055
      • Besancon, França, 25030
      • Besancon, França, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Bordeaux, França, 33075
      • Bordeaux, França, 33075
        • Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale
      • Dijon, França, 21079
        • Centre Georges Francois Leclerc; Oncologie 3
      • Dijon, França, 21079
      • La Tronche, França, 38700
      • La Tronche, França, 38700
        • Hopital Albert Michallon; Radiotherapie
      • Lille, França, 59020
      • Lille, França, 59020
        • Centre Oscar Lambret; Radiotherapie
      • Montbeliard, França, 25209
      • Montbeliard, França, 25209
        • Centre Hospitalier Andre Boulloche; Departement D'Oncologie
      • Montpellier, França, 34928
      • Montpellier, França, 34928
        • Centre Val Aurelle Paul Lamarque; Radiotherapie
      • Nancy, França, 54100
      • Nancy, França, 54100
        • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
      • Nice, França, 06189
        • Centre Antoine Lacassagne; Hopital De Jour A2
      • Nice, França, 06189
      • Paris, França, 75970
        • HOPITAL TENON; Cancerologie Medicale
      • Paris, França, 75970
      • Paris, França, 75651
      • Paris, França, 75475
      • Paris, França, 75651
        • Ch Pitie Salpetriere; Oncologie Medicale
      • Paris, França, 75475
        • Hopital Saint Louis; Radiotherapie Oncologie
      • Pierre Benite, França, 69495
      • Pierre Benite, França, 69495
        • Ch Lyon Sud; Radiotherapie Sct Jules Courmont
      • Poitiers, França, 86021
      • Poitiers, França, 86021
        • Chu La Miletrie; Radiotherapie
      • Saint Herblain, França, 44805
        • Ico Rene Gauducheau; Oncologie
      • Saint Herblain, França, 44805
      • Strasbourg, França, 67065
        • Centre Paul Strauss; Oncologie Medicale
      • Strasbourg, França, 67065
      • Toulouse, França, 31078
      • Toulouse, França, 31078
        • Polyclinique Du Parc; Centre De Hautes Energies
      • Tours, França, 37044
      • Tours, França, 37044
        • Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
      • Vandoeuvre Les Nancy, França, 54511
      • Vandoeuvre Les Nancy, França, 54511
        • Centre Alexis Vautrin; Oncologie Medicale

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • histologically confirmed locally advanced rectal cancer;
  • measurable disease;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion Criteria:

  • prior treatment with bevacizumab;
  • prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
  • previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
  • history or evidence of central nervous system (CNS) disease;
  • clinically significant cardiovascular disease;
  • chronic treatment with high dose aspirin (more than [>] 325 milligrams per day [mg/day]) or non-steroidal anti-inflammatory drugs.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy)
In this arm, participants will undergo 3 phases of treatment. During the Phase 1, participants will receive induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (intravenous [IV] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 will be surgery involving a radical rectal excision using the total mesorectal excision (TME) technique.
Medicamento: Bevacizumab
Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.
Outros nomes:
  • AvastinName
Medicamento: Oxaliplatin
Oxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m^2) as a 2-hour IV infusion.
Medicamento: Folinic Acid
Folinic acid will be administered at a dose of 200 mg/m^2 as a 2-hour infusion.
Medicamento: 5-fluorouracil
5-fluorouracil will be administered at a dose of 400 mg/m^2 as an IV bolus, then at a dose of 600 mg/m^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.
Radiação: Preoperative Radiotherapy
Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.
Procedimento: Surgery
Radical rectal excision based on the TME technique.
Experimental: Arm B (Bevacizumab, Chemoradiotherapy)
In this arm, participants will receive the Phase 2 and Phase 3 treatments only. The phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 will be surgery involving a radical rectal excision using the TME technique.
Medicamento: Bevacizumab
Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.
Outros nomes:
  • AvastinName
Medicamento: 5-fluorouracil
5-fluorouracil will be administered at a dose of 400 mg/m^2 as an IV bolus, then at a dose of 600 mg/m^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.
Radiação: Preoperative Radiotherapy
Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.
Procedimento: Surgery
Radical rectal excision based on the TME technique.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With Tumor Sterilization Defined by ypT0-N0
Prazo: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Tumor sterilization was defined as the absence of residual tumor cells in the resected specimen including lymph nodes (ypT0-N0). The rate of sterilization of the tumoral specimen was assessed after surgery on the surgical specimen by local review. Analyses were performed for participants who have been operated as defined by the protocol (within the study and TME technique) and for all participants who have been operated. Reported is the percentage of participants with tumor sterilization.
After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With Tumor Down-Staging (ypT0-pT2)
Prazo: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
A participant with a downstaging was defined as a participant with T3 (T describes the size of the original [primary] tumor) at inclusion and T2 or T1 or T0 after surgery, or with N+ (N describes lymph nodes involvement) at inclusion and N- after surgery and if T is equal at inclusion and after surgery. The clinical tumor-node-metastasis (cTNM) classification was used at inclusion and the pathological staging tumor and nodes (ypTN) classification after surgery. Reported is the percentage of participants with tumor downstaging of the surgical specimen according to the local review and centralized review.
After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Percentage of Participants With Local and Distant Recurrences
Prazo: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
The percentage of participants with a recurrence was described by type of recurrence (local and distant recurrence).
After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death
Prazo: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Disease-Free Survival (DFS)
Prazo: From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)
The DFS was defined as the time from the first treatment intake to disease recurrence assessed (second primary cancer, local or distant recurrence, distant metastases) or death from any cause. The DFS was analyzed using Kaplan-Meier method.
From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)
Percentage of Participants Who Died
Prazo: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Overall Survival
Prazo: From the first treatment administration to the date of death (up to approximately 6 years)
The overall survival was defined as the time from the first treatment intake to death from any cause.
From the first treatment administration to the date of death (up to approximately 6 years)
Number of Cycles of Induction Chemotherapy
Prazo: 6 cycles (12 weeks; cycle length = 14 days)
6 cycles (12 weeks; cycle length = 14 days)
Number of Cycles of Chemotherapy
Prazo: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Number of Cycles of Radiotherapy
Prazo: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Percentage of Participants With Surgery
Prazo: Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment
The surgery involving a radical rectal excision using the TME technique.
Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoffmann-La Roche

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de outubro de 2007

Conclusão Primária (Real)

23 de março de 2016

Conclusão do estudo (Real)

23 de março de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

18 de março de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de março de 2009

Primeira postagem (Estimativa)

19 de março de 2009

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de agosto de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de julho de 2017

Última verificação

1 de julho de 2017

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ML19202
  • 2006-003472-35 (Número EudraCT)

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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