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Chemotherapy and Bevacizumab With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer

20 de septiembre de 2012 actualizado por: European Organisation for Research and Treatment of Cancer - EORTC

CLOCC Trial (Chemotherapy + Local Ablation Versus Chemotherapy) Randomized Phase II Study Of Local Treatment Of Liver Metastases By Radiofrequency Combined With Chemotherapy Versus Chemotherapy Alone In Patients With Unresectable Colorectal Liver Metastases

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread by blocking blood flow. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases.

PURPOSE: This randomized phase II trial is studying combination chemotherapy, bevacizumab, and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

Primary

  • Compare the 30-month overall survival rate of patients with unresectable liver metastases secondary to colorectal adenocarcinoma treated with chemotherapy and bevacizumab with or without radiofrequency interstitial ablation.

Secondary

  • Compare overall survival of patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Determine the health economics associated with this study.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to treatment center, prior adjuvant chemotherapy for primary cancer (yes vs no), prior chemotherapy for liver metastases (yes vs no), and route of randomization (before surgery vs during surgery). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Within 4 weeks of randomization, patients undergo radiofrequency interstitial ablation (RFA) with or without additional resection of resectable lesions. Within 8 weeks after RFA, patients receive chemotherapy and bevacizumab.
  • Arm II: Within 4 weeks of randomization, patients receive chemotherapy and bevacizumab.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients in both arms receive one of the following chemotherapy and bevacizumab regimens to be determined by participating center:

  • Regimen A: Patients receive oxaliplatin IV over 2 hours on day 1 of weeks 1, 3, and 5 and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours on day 1 of weeks 1-6 and bevacizumab IV over 30-90 minutes on days 1 or 2, 15 or 16, and 29 or 30. Treatment repeats every 7 weeks for 4 courses.
  • Regimen B: Patients receive oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours and bevacizumab IV over 30-90 minutes on day 1 or 3. Treatment repeats every 15 days for 12 courses.
  • Regimen C: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on days 1 and 2 and bevacizumab IV over 30-90 minutes on day 1 or 3. Treatment repeats every 15 days for 12 courses.

Quality of life is assessed at baseline, within 1 week after completion of RFA (arm I only), within 1 week before start of chemotherapy (arm I only), at weeks 6, 12, 18, and 24 during chemotherapy, every 3 months for 2 years after treatment, and then every 6 months thereafter.

After completion of study treatment, patients are followed every 3 months for 2½ years and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 152 patients (71 per treatment arm) will be accrued for this study within 3 years.

Tipo de estudio

Intervencionista

Inscripción (Actual)

119

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, D-13122
        • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
      • Essen, Alemania, D-45136
        • Kliniken Essen - Mitte
      • Frankfurt, Alemania, D-60590
        • Klinikum der J.W. Goethe Universitaet
      • Frankfurt, Alemania, D-65929
        • Staedtische Kliniken Frankfurt am Main - Hoechst
      • Regensburg, Alemania, D-93053
        • Klinikum der Universitaet Regensburg
  • Austria
      • Vienna, Austria, A-1090
        • Allgemeines Krankenhaus - Universitatskliniken
  • Bélgica
      • Antwerp, Bélgica, 2020
        • Ziekenhuis Netwerk Antwerpen Middelheim
      • Brussels, Bélgica, 1000
        • Institut Jules Bordet
      • Edegem, Bélgica, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Ghent, Bélgica, B-9000
        • Universitair Ziekenhuis Gent
      • Mont-Godinne Yvoir, Bélgica, 5530
        • Clinique Universitaire De Mont-Godinne
  • Egipto
      • Cairo, Egipto
        • National Cancer Institute - Cairo
  • Francia
      • Angers, Francia, 49033
        • Centre Hospitalier Regional et Universitaire d'Angers
      • Boulogne Billancourt, Francia, F-92104
        • Centre Hospitalier Universitaire Ambroise Pare - Boulogne
      • Strasbourg, Francia, 67098
        • Hopital Universitaire Hautepierre
      • Vandoeuvre-les-Nancy, Francia, 54511
        • Centre Alexis Vautrin
  • Hungría
      • Budapest, Hungría, 1122
        • National Institute of Oncology
  • Italia
      • Rome, Italia, 00152
        • Azienda Ospedaliera S. Camillo-Forlanini
  • Países Bajos
      • 's-Hertogenbosch, Países Bajos, 5211 NL
        • Jeroen Bosch Ziekenhuis
      • Amsterdam, Países Bajos, 1066 CX
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
      • Breda, Países Bajos, 4800 RL
        • Amphia Ziekenhuis - locatie Langendijk
      • Enschede, Países Bajos, 7500 KA
        • Medisch Spectrum Twente
      • Heerlen, Países Bajos, 6401 CX
        • Atrium Medical Centre - Heerlen
      • Leeuwarden, Países Bajos, 8934 AD
        • Medisch Centrum Leeuwarden - Zuid
      • Maastricht, Países Bajos, 6202 AZ
        • Academisch Ziekenhuis Maastricht
      • Nijmegen, Países Bajos, NL-6500 HB
        • Universitair Medisch Centrum St. Radboud - Nijmegen
      • Utrecht, Países Bajos, 3584 CX
        • University Medical Center Utrecht
      • Veldhoven, Países Bajos, 5500 MB
        • Maxima Medisch Centrum - Veldhoven
  • Reino Unido
    • England
      • Birmingham, England, Reino Unido, B15 2TH
        • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
      • Bristol, England, Reino Unido, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Leicester, England, Reino Unido, LE5 4PW
        • Leicester General Hospital
      • Liverpool, England, Reino Unido, L69 3GA
        • Royal Liverpool University Hospital
      • London, England, Reino Unido, NW1 2ND
        • Cancer Research UK and University College London Cancer Trials Centre
      • London, England, Reino Unido, WIT 3AA
        • University College of London Hospitals
      • Manchester, England, Reino Unido, M13 9WL
        • Manchester Royal Infirmary
      • Merseyside, England, Reino Unido, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Oxford, England, Reino Unido, OX3 7LJ
        • Churchill Hospital
      • Southampton, England, Reino Unido, SO14 0YG
        • Royal South Hants Hospital
    • Wales
      • Cardiff, Wales, Reino Unido, CF14 2TL
        • Velindre Cancer Center at Velindre Hospital
      • Rhyl, Denbighshire, Wales, Reino Unido, LL 18 5UJ
        • Glan Clywd District General Hospital
  • Suecia
      • Gothenburg (Goteborg), Suecia, S-413 45
        • Sahlgrenska University Hospital at Gothenburg University
      • Stockholm, Suecia, S - 141 86
        • Karolinska University Hospital - Huddinge
      • Uppsala, Suecia, SE 75185
        • Uppsala University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

DISEASE CHARACTERISTICS:

  • Unresectable liver metastases secondary to colorectal adenocarcinoma, including:

    • Metastases that cannot be radically resected due to size, location, or number of deposits
    • Metastases invading right and left branches of hepatic artery or portal vein
    • Metastases extended to the 3 main hepatic veins
  • No detectable extra-hepatic disease
  • Fewer than 10 metastatic deposits on liver
  • Total metastatic involvement of liver no more than 50%

  • Adequate treatment of all metastatic lesions deemed possible either by radiofrequency interstitial ablation (RFA) alone or by a combination of resection of resectable lesions and RFA of the remaining unresectable lesions

    • Maximum diameter of 4 cm for lesions to be treated with RFA
    • No maximum diameter of lesions to be resected as long as negative resection margins are obtainable
  • If synchronous liver metastases, must have undergone prior resection of primary tumor

PATIENT CHARACTERISTICS:

Age

  • 18 to 80

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • No bleeding disorder or coagulopathy or need for full-dose anticoagulation

Hepatic

  • Bilirubin less than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 3 times ULN

Renal

  • Creatinine less than 2 times ULN
  • Protein < 0.5 g/24 hr urine collection if proteinuria positive by dipstick

Cardiovascular

  • No uncontrolled congestive heart failure
  • No uncontrolled angina pectoris
  • No uncontrolled hypertension
  • No uncontrolled arrhythmia
  • No myocardial infarction within the past 12 months
  • No cerebrovascular accident or transient ischemic attack within the past 6 months

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No greater than grade 1 peripheral neuropathy
  • No significant neurologic or psychiatric disorder
  • No active infection
  • No contraindication to the use of fluorouracil, leucovorin calcium, oxaliplatin, or bevacizumab
  • No other malignancy within the past 10 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy except for metastatic disease confined to the liver

    • Prior fluorouracil, leucovorin calcium, and oxaliplatin allowed if administered for at least 3 courses (2 weeks each) but no longer than 3 months with at least stabilization of disease achieved
  • Prior adjuvant chemotherapy for primary cancer allowed except for patients who received oxaliplatin and have been diagnosed with metastatic disease within 12 months after completion of adjuvant treatment

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • More than 28 days since major surgery or open biopsy past 28 days
  • More than 28 days since significant traumatic injury

Other

  • No other concurrent investigational treatment
  • No other concurrent anticancer therapy

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Enmascaramiento: Ninguno (etiqueta abierta)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Survival rate as measured by Kaplan Meier method at 30 months

Medidas de resultado secundarias

Medida de resultado
Overall survival as measured by Logrank every 3 months for 30 months then every 6 months thereafter
Progression-free survival as measured by Logrank every 3 months for 30 months then every 6 months thereafter
Toxicity as measured by CTC version 2.0 every 3 months for 30 months then every 6 months thereafter
Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) version 3.0 at baseline, weeks 6, 12, 18, and 24, every 3 months for years 1-2 after start of treatment, then every 6 months thereafter
Response to treatment (arm II) as measured by RECIST criteria from start of treatment until disease progression

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

European Organisation for Research and Treatment of Cancer - EORTC

Colaboradores

Institute of Cancer Research, United Kingdom
Arbeitsgruppe Lebermetastasen und Tumoren

Investigadores

  • Silla de estudio: Wolf O. Bechstein, MD, Arbeitsgruppe Lebermetastasen und Tumoren
  • Silla de estudio: Theo Ruers, MD, Universitair Medisch Centrum St. Radboud - Nijmegen
  • Silla de estudio: Jonathan A. Ledermann, MD, Cancer Research UK

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2002

Finalización primaria (Actual)

1 de junio de 2007

Fechas de registro del estudio

Enviado por primera vez

5 de agosto de 2002

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2003

Publicado por primera vez (Estimar)

27 de enero de 2003

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de septiembre de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

20 de septiembre de 2012

Última verificación

1 de septiembre de 2012

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • EORTC-40004
  • ALM-CAO-EORTC-40004
  • NCRI-EORTC-40004

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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