- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01836653
Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases (ATOM)
Randomized Phase II Study of mFOLFOX6 + Bevacizumab or mFOLFOX6 + Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
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Tokyo
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Shinjuku-ku, Tokyo, Japão, 162-0814
- EPS Corporation
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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:
- Histopathologically confirmed colorectal cancer (adenocarcinoma) excluding vermiform appendix cancer and proctos cancer.
- RAS wild type
Synchronous* or metachronous liver limited meitastasis with no extrahepatic desiease
- shychronous liver limited metastasis with primary lesion less than two thirds of the circumference
- patients with primary lesion more than two thirds of the circumference can be enrolled after primary resection
- Patients who has one or more lesion(s) of diameter 1 cm or larger (RECEST v1.1) be able to assess continuously on the basis of the protocol by contrast enhanced CT or contrast enhanced MRI of the liver:
(1)Liver metastases 5 or more (2)Liver metastases with 5 cm or larger in greatest dimension (3)Unresectable considering remaining hepatic function (4)Invasion into all hepatic veins or inferior vena cava (5)Invasion into both right and left hepatic arteries or portal veins 5.No prior chemotherapy for colorectal cancer including hepatic arterial infusion. Excluding postoperative and preoperative chemoradiotherapy except for rectal cancer with synchronous liver metastases. Patients received postoperative chemotherapy containing oxaliplatin have to be enrolled after 24 weeks from the last oxaliplatin administration.
6.No previous treatment including ablation therapy, cryotherapy and chemotherapy for metastases 7.Age at enrollment is >=20 and =<80 years 8.The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 9.Life expectancy from the day of enrollment is 3 months or longer 10.Major organ functions less than 14 days prior to entry meet the following criteria.
- Neu >= 1500/mm3
- Pt >= 10.0x10^4/mm3
- Hb >= 9.0 g/dL
- T-bil =< 2.0 mg/dL
- AST and ALT =< 200 IU/L
- sCr =< 1.20 mg/dL
- INR < 1.5
- Proteinuria =< 2+ 11.Written informed consent
Exclusion Criteria:
- Previously experienced severe allergic reaction to drugs
- Receiving anti-platelet drugs (aspirin >= 325 mg/day) or NSAIDs
- Receiving chronic systemic corticosteroid treatment
- Surgery/ biopsy with skin incision or traumatic injury with suture less than 14 days prior to entry. Excluding, suture for implanted venous reservoirs with catherter is allowed.
- Severe postoperative complications (e.g. postoperative infection, anastomic dehiscence or paralytic ileus)
- Diagnosed as hereditary colorectal cancer
- Active other malignancies
- Cerebrovascular disease or symptoms less than 1 year prior to entry
- Pleural effusion, ascites or cardiac effusion requiring drainage
- Hemorrhage/bleeding, paralytic ileus, obstruction or ulceration of gastrointestinal tract
- Perforation of gastrointestinal tract less than 1 year prior to entry
- Presence of active infection
- HBs antigen or HCV antibody positive
- Uncontrolled comorbidity including hypertension, diabetes, arrhythmia, or other diseases (such as cardiac disorder, interstitial pneumonia or renal disorder)
- Presence of >= grade 2 diarrhea
- Presence of >= grade 1 peripheral neuropathy
- Pregnant or lactating women. Women and men with childbearing potential unwilling to use effective means of contraception
- Psychosis or psychiatric symptoms who are not able to comply with the protocol
- Any other medical conditions disable to comply with the protocol
Plano de estudo
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: mFOLFOX + Bmab
mFOLFOX plus bevacizumab
|
5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Outros nomes:
85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Outros nomes:
200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Outros nomes:
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Outros nomes:
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Outros nomes:
|
|
Comparador Ativo: mFOLFOX + Cmab
mFOLFOX plus cetuximab
|
85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Outros nomes:
200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Outros nomes:
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Outros nomes:
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Outros nomes:
250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-free survival
Prazo: assessed every 8 weeks, up to 4 years
|
assessed by Independent Review Committee
|
assessed every 8 weeks, up to 4 years
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Response rate
Prazo: assessed every 8 weeks, up to 4 years
|
assessed every 8 weeks, up to 4 years
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Tumor shrinkage rate at 8 week
Prazo: assessed at 8 week, up to 8 weeks
|
assessed at 8 week, up to 8 weeks
|
|
|
Liver resection rate
Prazo: assessed every 8 weeks, up to 4 years
|
assessed every 8 weeks, up to 4 years
|
|
|
R0 liver resection rate
Prazo: assessed every 8 weeks, up to 4 years
|
pathologically confirmed R0 liver resection rate
|
assessed every 8 weeks, up to 4 years
|
|
Progression-free survival
Prazo: assessed every 8 weeks, up to 4 years
|
assessed by investigators
|
assessed every 8 weeks, up to 4 years
|
|
Time to treatment-failure
Prazo: assessed every 2 weeks, up to 4 years
|
assessed every 2 weeks, up to 4 years
|
|
|
Overall survival
Prazo: assessed every 2 weeks, up to 4 years
|
assessed every 2 weeks, up to 4 years
|
|
|
Quality of life
Prazo: assessed every 16 weeks, up to 1 year
|
assessed every 16 weeks, up to 1 year
|
|
|
Incidence of adverse events
Prazo: assessed every 2 weeks, up to 4 years
|
assessed every 2 weeks, up to 4 years
|
|
|
Progression-free survival among the RAS wild type subpopulation
Prazo: assessed every 8 weeks, up to 4 years
|
All the assessment is repeated for a maximum of 4 years.
|
assessed every 8 weeks, up to 4 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yoshihiko Maehara, MD,PhD,FACS, Graduate School of Medical Science, Kyushu University, Department of Surgery and Science
- Investigador principal: Naohiro Tomita, MD, PhD, Hyogo College of Medicine, Department of Surgery
- Investigador principal: Ichinosuke Hyodo, MD, PhD, Tsukuba University, Graduate School of Medicine
- Investigador principal: Michiaki Unno, MD, PhD, Tohoku University, Division of Gastroenterological Surgery
Publicações e 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 (Real)
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
- Doenças do aparelho digestivo
- Processos Patológicos
- Neoplasias
- Neoplasias por local
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças Gastrointestinais
- Doenças do cólon
- Doenças Intestinais
- Neoplasias Intestinais
- Doenças retais
- Processos Neoplásicos
- Neoplasias Colorretais
- Neoplasia Metástase
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes Antineoplásicos Imunológicos
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Fluorouracil
- Oxaliplatina
- Bevacizumabe
- Cetuximabe
Outros números de identificação do estudo
- ATOM (Radius Health, Inc.)
- UMIN000010209 (Outro identificador: UMIN)
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