- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00537823
Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement
Effect of Short-duration Preoperative Neoadjuvant Therapy With FOLFOX Based Therapy on Morbidity After Liver Resection for Colorectal Cancer Metastases
Visão geral do estudo
Status
Condições
Descrição detalhada
Although early stage, localized colon and rectal cancers are associated with 5 year survival rates of nearly 90%, only a minority of patients present with localized disease. Unfortunately, at the time of their initial presentation, approximately 35% of patients with colon or rectal cancer have metastatic disease. Nearly two thirds of these patients with stage IV disease have evidence of extrahepatic spread and have a median overall survival rate of 8-10 months in the absence of further treatment. Even with the most intensive chemotherapeutic regimens, the median overall survival for these patients ranges from 12 months to 20 months. However, a small subset of patients with stage IV disease has isolated hepatic metastatic disease and can undergo resection. The patients with completely resected liver metastases enjoy a significantly higher overall five-year survival, which is as high as 58% in carefully selected patients. Ten-year overall survival has been reported in 22% of patients. Despite this improvement, the five-year disease-free survival for these patients is at best 35%, with hepatic recurrences occurring in 46%.
The fact that adjuvant chemotherapy improves the three-year survival rate for stage II disease and five-year survival rates for stage III disease implies that it can treat micrometastatic disease in some fraction of patients. Because micrometastatic disease is likely the cause of the high recurrence rate in patients who undergo liver resection, there is a clear biologic rationale for using postoperative adjuvant chemotherapy after liver resection. Although this strategy is a common practice in many centers, no convincing data that this improves survival have been reported. A large randomized phase III trial (EORTC 40983) examining this question is currently ongoing and effect on survival has not yet been reported. Given that systemic chemotherapy after liver resection remains of unproven benefit at the present time, many have wondered if preoperative treatment might have more promise in improving recurrence rates.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Missouri
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St. Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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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:
- Synchronous or metachronous colorectal metastases
Technically resectable liver metastases
- Four or fewer metastases
- No tumors in porta hepatis
- Resection of no more than 70% of liver needed
- Medically suitable candidate for major liver resection
- FDG-PET scan without metastatic disease outside the liver
Exclusion Criteria:
- Near-obstructing or obstructing colon lesions in patients in whom combined resection is planned (as delay for preoperative chemotherapy would be medially impossible)
- Treatment with FOLFOX or cetuximab within 12 months
- Treatment with irinotecan within 12 months
- Abnormal liver function (ALT or AST > 5x ULN, bilirubin > 3x ULN)
- Body mass index >/= 35 kg/m² (as the risk for steatohepatitis is increased)
- Renal insufficiency (Cr > 2.5mg/dL)
- Interstitial lung disease (because cetuximab has been rarely associated with development of interstitial lung disease)
- ECOG performance score >/= 3
- Patients unable to give informed consent
- Pregnant patient (as cetuximab is a Class C drug)
- Peripheral neuropathy >/= grade II (as oxaliplatin causes neuropathy to worsen)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Arm 1 - Wildtype
Neoadjuvant therapy Week 1
Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly Weeks 3, 5, 7
Wait 3-8 weeks after completion of therapy Liver resection Wait 4 weeks or until clinical status allows Adjuvant Therapy Week 1, 3, 5, 7, 9, 11, 13, 15
Weeks 2, 4, 6, 8, 10, 12, 16 *Cetuximab 250 mg/m^2 IV weekly |
Outros nomes:
|
Experimental: Arm 2 K-Ras 12/13 codon mutation
Neoadjuvant Therapy Weeks 1, 3, 5
Week 7
Wait 3-8 weeks after completion of therapy Liver resection Wait 4 weeks or until clinical status allows Adjuvant Therapy Weeks 1, 3, 5, 9, 11, 13
Week 7, 15
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Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Postoperative Complication Rate
Prazo: 30 days following surgery
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Fraction of patients with any grade of complication I-V
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30 days following surgery
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Major Postoperative Complication Rate
Prazo: 30 days following surgery
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Fraction of patients with any complication grades IV and V
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30 days following surgery
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All-cause Mortality
Prazo: 30 days following surgery
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30 days following surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Postoperative Recurrence Patterns
Prazo: Up to 5 years
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Liver only vs distant disease
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Up to 5 years
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Histologic Hepatic Toxicity at Surgery
Prazo: Time of surgery (approximately 11-16 weeks)
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Time of surgery (approximately 11-16 weeks)
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Nonalcoholic Steatohepatitis Score (0-3)
Prazo: Time of surgery (approximately 11-16 weeks)
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Time of surgery (approximately 11-16 weeks)
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Liver Injury Scale Score (0-27)
Prazo: Time of surgery (approximately 11-16 weeks)
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Time of surgery (approximately 11-16 weeks)
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Effect of Preoperative Chemotherapy on Tumor Size
Prazo: Upon completion of neoadjuvant chemotherapy (approximately 2 months)
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Number of participants whose tumor size decreased from baseline to completion of preoperative chemotherapy.
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Upon completion of neoadjuvant chemotherapy (approximately 2 months)
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Change in Tumor Size From Pretreatment to Preoperative CT Scan
Prazo: Completion of neoadjuvant therapy (approximately 8 weeks)
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-Compare total longest diameter from baseline to preoperative CT scan.
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Completion of neoadjuvant therapy (approximately 8 weeks)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David Linehan, M.D., Washington University School of Medicine
Publicações e links úteis
Publicações Gerais
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- Fernandez FG, Ritter J, Goodwin JW, Linehan DC, Hawkins WG, Strasberg SM. Effect of steatohepatitis associated with irinotecan or oxaliplatin pretreatment on resectability of hepatic colorectal metastases. J Am Coll Surg. 2005 Jun;200(6):845-53. doi: 10.1016/j.jamcollsurg.2005.01.024.
- Vauthey JN, Pawlik TM, Ribero D, Wu TT, Zorzi D, Hoff PM, Xiong HQ, Eng C, Lauwers GY, Mino-Kenudson M, Risio M, Muratore A, Capussotti L, Curley SA, Abdalla EK. Chemotherapy regimen predicts steatohepatitis and an increase in 90-day mortality after surgery for hepatic colorectal metastases. J Clin Oncol. 2006 May 1;24(13):2065-72. doi: 10.1200/JCO.2005.05.3074.
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- Scappaticci FA, Fehrenbacher L, Cartwright T, Hainsworth JD, Heim W, Berlin J, Kabbinavar F, Novotny W, Sarkar S, Hurwitz H. Surgical wound healing complications in metastatic colorectal cancer patients treated with bevacizumab. J Surg Oncol. 2005 Sep 1;91(3):173-80. doi: 10.1002/jso.20301.
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- Adam R, Aloia T, Figueras J, Capussotti L, Poston G, Mentha G, Selzner M, and the LiverMetSurvey Scientific Committee. LiverMetSurvey: Analysis of clinicopathologic factors associated with the efficacy of preoperative chemotherapy in 2,122 patients with colorectal liver metastases. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 3521.
- Adam R, Avisar E, Ariche A, Giachetti S, Azoulay D, Castaing D, Kunstlinger F, Levi F, Bismuth F. Five-year survival following hepatic resection after neoadjuvant therapy for nonresectable colorectal. Ann Surg Oncol. 2001 May;8(4):347-53. doi: 10.1007/s10434-001-0347-3.
- Badarinath S, Mitchell EP, Jennis A, Graham CD, Hansen VL, Henderson CA, Chen TT, Langer C. Cetuximab plus FOLFOX for colorectal cancer (EXPLORE): Preliminary safety analysis of a randomized phase III trial. Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 3531.
- Bilchik AJ, Poston G, Curley SA, Strasberg S, Saltz L, Adam R, Nordlinger B, Rougier P, Rosen LS. Neoadjuvant chemotherapy for metastatic colon cancer: a cautionary note. J Clin Oncol. 2005 Dec 20;23(36):9073-8. doi: 10.1200/JCO.2005.03.2334. No abstract available. Erratum In: J Clin Oncol. 2006 Apr 1;24(10):1648.
- Capussotti L, Muratore A, Ferrero A, Massucco P, Ribero D, Polastri R. Randomized clinical trial of liver resection with and without hepatic pedicle clamping. Br J Surg. 2006 Jun;93(6):685-9. doi: 10.1002/bjs.5301.
- Colucci G, Giuliani F, Mattioli R, Garufi C, Mallamaci R, Pezzella G, Lopez M, Maiello E. FOLFOX-4 + cetuximab in untreated patients with advanced colorectal cancer. A phase II study of the Gruppo Oncologico dell'Italia Meridionale . Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 3559.
- Dakhil S, Cosgriff T, Headley D, Badarinath S, International Oncology Network, R. V. Boccia. Cetuximab + FOLFOX6 as first line therapy for metastatic colorectal cancer. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S, 2006: 3557
- D'Angelica M, Maddineni S, Fong Y, Martin RC, Cohen MS, Ben-Porat L, Gonen M, DeMatteo RP, Blumgart LH, Jarnagin WR. Optimal abdominal incision for partial hepatectomy: increased late complications with Mercedes-type incisions compared to extended right subcostal incisions. World J Surg. 2006 Mar;30(3):410-8. doi: 10.1007/s00268-005-0183-x.
- Delaunoit T, Alberts SR, Sargent DJ, Green E, Goldberg RM, Krook J, Fuchs C, Ramanathan RK, Williamson SK, Morton RF, Findlay BP. Chemotherapy permits resection of metastatic colorectal cancer: experience from Intergroup N9741. Ann Oncol. 2005 Mar;16(3):425-9. doi: 10.1093/annonc/mdi092. Epub 2005 Jan 27.
- Díaz Rubio E, JTabernero J, van Cutsem E, Cervantes A, André T, Humblet Y, Soulié P, Corretgé S, Kisker O,de Gramont A. Cetuximab in combination with oxaliplatin/5-fluorouracil (5-FU)/folinic acid (FA) (FOLFOX-4) in the first-line treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer: An international phase II study. Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings. Vol 23, No. 16S, Part I of II (June 1 Supplement), 2005: 3535.
- Ellis LM, Curley SA, Grothey A. Surgical resection after downsizing of colorectal liver metastasis in the era of bevacizumab. J Clin Oncol. 2005 Aug 1;23(22):4853-5. doi: 10.1200/JCO.2005.23.754. No abstract available.
- Fausto N, Campbell JS, Riehle KJ. Liver regeneration. Hepatology. 2006 Feb;43(2 Suppl 1):S45-53. doi: 10.1002/hep.20969.
- Fernandez FG, Drebin JA, Linehan DC, Dehdashti F, Siegel BA, Strasberg SM. Five-year survival after resection of hepatic metastases from colorectal cancer in patients screened by positron emission tomography with F-18 fluorodeoxyglucose (FDG-PET). Ann Surg. 2004 Sep;240(3):438-47; discussion 447-50. doi: 10.1097/01.sla.0000138076.72547.b1.
- Finkelstein SE, Fernandez FG, Dehdashti F, Siegel BA, Hawkins WG, Linehan DC, Strasberg SM. Unique site- and time-specific patterns of recurrence following resection of colorectal carcinoma hepatic metastases in patients staged by FDG-PET. J Hepatobiliary Pancreat Surg. 2008;15(5):483-7. doi: 10.1007/s00534-007-1237-2. Epub 2008 Oct 4.
- Gruenberger T, Sorbye H, Debois M, Bethe U, Primrose J, Rougier P, Jaeck D, Finch-Jones M, Van Cutsem E, Nordlinger B. Tumor response to pre-operative chemotherapy (CT) with FOLFOX-4 for resectable colorectal cancer liver metastases (LM). Interim results of EORTC Intergroup randomized phase III study 40983. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 3500.
- Ibrahim S, Chen CL, Wang CC, Wang SH, Lin CC, Liu YW, Yang CH, Yong CC, Concejero A, Cheng YF. Liver regeneration and splenic enlargement in donors after living-donor liver transplantation. World J Surg. 2005 Dec;29(12):1658-66. doi: 10.1007/s00268-005-0101-2.
- Jennis A , J. Polikoff, E. Mitchell, S. Badarinath, C. Graham, T. Chen, T. Gustafson, C. Langer Erbitux (Cetuximab) Plus FOLFOX for Colorectal Cancer (EXPLORE): Preliminary efficacy analysis of a randomized phase III trial. Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings. Vol 23, No. 16S, Part I of II (June 1 Supplement), 2005: 3574
- Karoui M, Penna C, Amin-Hashem M, Mitry E, Benoist S, Franc B, Rougier P, Nordlinger B. Influence of preoperative chemotherapy on the risk of major hepatectomy for colorectal liver metastases. Ann Surg. 2006 Jan;243(1):1-7. doi: 10.1097/01.sla.0000193603.26265.c3.
- Koniaris LG, McKillop IH, Schwartz SI, Zimmers TA. Liver regeneration. J Am Coll Surg. 2003 Oct;197(4):634-59. doi: 10.1016/S1072-7515(03)00374-0. No abstract available.
- Lorenz M, Staib-Sebler E, Gog C, Proschek D, Jauch KW, Ridwelski K, Hohenberger W, Gassel HJ, Lehmann U, Vestweber KH, Padberg W, Zamzow K, Muller HH. Prospective pilot study of neoadjuvant chemotherapy with 5-fluorouracil, folinic acid and oxaliplatin in resectable liver metastases of colorectal cancer. Analysis of 42 neoadjuvant chemotherapies. Zentralbl Chir. 2003 Feb;128(2):87-94. doi: 10.1055/s-2003-37760.
- Nordlinger B, Sorbye H, Debois M, Praet M, Glimelius B, Poston GJ, P. Schlag M, Walpole ET, Bechstein W, Gruenberger T. Feasibility and risks of pre-operati ve chemotherapy (CT) with Folfox 4 and surgery for resectable colorectal cancer liver metastases (LM). Interim results of the EORTC Intergroup randomized phase III study 40983. Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings. Vol 23, No. 16S, Part I of II (June 1 Supplement), 2005: 3528.
- Portier G, Rougier P, Milan C et al. Adjuvant systemic chemotherapy using 5-fluorouracil and folinic acid after resection of liver metastases from colorectal origin. Results of an intergroup phase III study (trial FFCD-ACHBTH-AURC 9002). Proc Am Soc Clin Oncol (2002); 20:528 (abstr).
- Reddy GK. The addition of bevacizumab to FOLFOX4 prolongs survival in relapsed colorectal cancer: interim data from the ECOG 3200 trial. Clin Colorectal Cancer. 2005 Jan;4(5):300-1. doi: 10.1016/s1533-0028(11)70131-1. No abstract available.
- Schemmer P, Friess H, Hinz U, Mehrabi A, Kraus TW, Z'graggen K, Schmidt J, Uhl W, Buchler MW. Stapler hepatectomy is a safe dissection technique: analysis of 300 patients. World J Surg. 2006 Mar;30(3):419-30. doi: 10.1007/s00268-005-0192-9.
- Shah SA, Haddad R, Al-Sukhni W, Kim RD, Greig PD, Grant DR, Taylor BR, Langer B, Gallinger S, Wei AC. Surgical resection of hepatic and pulmonary metastases from colorectal carcinoma. J Am Coll Surg. 2006 Mar;202(3):468-75. doi: 10.1016/j.jamcollsurg.2005.11.008. Epub 2006 Jan 18.
- Tabernero JM, Van Cutsem E, Sastre J, Cervantes A, Van Laethem JL, Humblet Y, Soulié P, Corretgé S, Mueser M, De Gramont A; Vall d'Hebron. An international phase II study of cetuximab in combination with oxaliplatin/5-fluorouracil (5-FU)/folinic acid (FA) (FOLFOX-4) in the first-line treatment of patients with metastatic colorectal cancer (CRC) expressing Epidermal Growth Factor Receptor (EGFR). Preliminary results. Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 3512.
- Taieb J, Artru P, Paye F, Louvet C, Perez N, Andre T, Gayet B, Hebbar M, Goebel FM, Tournigand C, Parc R, de Gramont A. Intensive systemic chemotherapy combined with surgery for metastatic colorectal cancer: results of a phase II study. J Clin Oncol. 2005 Jan 20;23(3):502-9. doi: 10.1200/JCO.2005.05.082.
- Tanaka K, Adam R, Shimada H, Azoulay D, Levi F, Bismuth H. Role of neoadjuvant chemotherapy in the treatment of multiple colorectal metastases to the liver. Br J Surg. 2003 Aug;90(8):963-9. doi: 10.1002/bjs.4160.
- Venook A, Niedzwiecki D, Hollis D, Sutherland S, Goldberg R, Alberts S, Benson A, Wade J, Schilsky R, Mayer R. Phase III study of irinotecan/5FU/LV (FOLFIRI) or oxaliplatin/5FU/LV (FOLFOX) ± cetuximab for patients with untreated metastatic adenocarcinoma of the colon or rectum (MCRC): CALGB 80203 preliminary results. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 3509.
- Wei AC, Greig PD, Grant D, Taylor B, Langer B, Gallinger S. Survival after hepatic resection for colorectal metastases: a 10-year experience. Ann Surg Oncol. 2006 May;13(5):668-76. doi: 10.1245/ASO.2006.05.039. Epub 2006 Mar 10.
- Wolmark N, Wieand S, Kuebler JP, Colangelo L, and Smith RE. A phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon: Results of NSABP Protocol C-07. ASCO Meeting Abstracts 2005 23.
- Yedibela S, Elad L, Wein A, Dimmler A, Merkel S, Hohenberger W, Meyer T. Neoadjuvant chemotherapy does not increase postoperative complication rate after resection of colorectal liver metastases. Eur J Surg Oncol. 2005 Mar;31(2):141-6. doi: 10.1016/j.ejso.2004.07.030.
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
- 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 de proteção
- Agentes Antineoplásicos Imunológicos
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Micronutrientes
- Vitaminas
- Antídotos
- Complexo de Vitamina B
- Fluorouracil
- Oxaliplatina
- Bevacizumabe
- Leucovorina
- Cetuximabe
Outros números de identificação do estudo
- 07-0182
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