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

20 settembre 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

119

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Survival rate as measured by Kaplan Meier method at 30 months

Misure di risultato secondarie

Misura del risultato
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaboratori

Institute of Cancer Research, United Kingdom
Arbeitsgruppe Lebermetastasen und Tumoren

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2002

Completamento primario (Effettivo)

1 giugno 2007

Date di iscrizione allo studio

Primo inviato

5 agosto 2002

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

24 settembre 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 settembre 2012

Ultimo verificato

1 settembre 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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