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Combination Chemotherapy With or Without Cetuximab Before and After Surgery in Treating Patients With Resectable Liver Metastases Caused By Colorectal Cancer

22 gennaio 2013 aggiornato da: University of Southampton

A Prospective Randomised Open Label Trial of Oxaliplatin/Fluoropyrimidine Versus Oxaliplatin/Fluoropyrimidine Plus Cetuximab Pre and Post Operatively in Patients With Resectable Colorectal Liver Metastasis Requiring Chemotherapy

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without cetuximab in treating liver metastases caused by colorectal cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without cetuximab before and after surgery in treating patients with resectable liver metastases caused by colorectal cancer.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

  • Compare progression-free survival of patients with resectable colorectal liver metastases treated with neoadjuvant and adjuvant combination chemotherapy with vs without cetuximab.

Secondary

  • Compare the overall survival of patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the cost effectiveness of these regimens in these patients.

OUTLINE: This is a prospective, randomized, multicenter, open-label study. Patients are stratified according to participating center and assigned chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms.

  • Neoadjuvant therapy:

    • Arm I: Patients receive 1 of the following chemotherapy regimens:

      • OxMdG: Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
      • CAPOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

    • Arm II: Patients receive 1 of the following regimens:

      • OxMdG + cetuximab: Patients receive cetuximab IV over 1-2 hours on day 1 and OxMdG chemotherapy as in arm I. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
      • CAPOX + cetuximab: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15 and CAPOX chemotherapy as in arm I. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • Surgery: Beginning 2-6 weeks after completion of chemotherapy, patients in both arms undergo liver resection.

  • Adjuvant therapy: Beginning 4-8 weeks after completion of surgery, patients receive treatment (OxMdG or CAPOX with or without cetuximab) as in arm I or II of neoadjuvant therapy.

    • Arm I: Treatment with OxMdG repeats every 2 weeks for up to 6 courses and treatment with CAPOX repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
    • Arm II: Treatment with OxMdG + cetuximab repeats every 2 weeks for up to 6 courses and treatment with CAPOX + cetuximab repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 12 weeks during chemotherapy, at completion of study treatment, every 3 months for 1 year, and then every 6 months thereafter.

Cost per life year and per quality-adjusted life year is assessed at baseline, every 12 weeks during treatment, and then at 3, 5, and 10 years.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Tipo di studio

Interventistico

Iscrizione (Anticipato)

340

Fase

  • Fase 3

Contatti e Sedi

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

Contatto studio

  • Nome: Louisa Little
  • Numero di telefono: 02380795154

Luoghi di studio

  • Regno Unito
    • England
      • Basildon, England, Regno Unito, SS16 5NL
        • Reclutamento
        • Basildon University Hospital
        • Contatto:
          • Pauline Leonard, MD
          • Numero di telefono: 44-1702-435-555
      • Basingstoke, England, Regno Unito, RG24 9NA
        • Reclutamento
        • Basingstoke and North Hampshire NHS Foundation Trust
        • Contatto:
          • Charlotte Rees, MD
          • Numero di telefono: 44-125-631-4793
      • Bournemouth, England, Regno Unito, BH7 7DW
        • Reclutamento
        • Royal Bournemouth Hospital
        • Contatto:
      • Cambridge, England, Regno Unito, CB2 0QQ
      • Guildford, England, Regno Unito, GU2 7XX
        • Reclutamento
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
        • Contatto:
          • Sharadah Essapen, MD
          • Numero di telefono: 44-1483-571-122
      • Liverpool, England, Regno Unito, L9 7AL
        • Reclutamento
        • Aintree University Hospital
        • Contatto:
      • Liverpool, England, Regno Unito, L9 7AL
        • Reclutamento
        • Royal Liverpool University Hospital
        • Contatto:
          • Paula Ghaneh, MD
      • London, England, Regno Unito, SW3 6JJ
        • Reclutamento
        • Royal Marsden - London
        • Contatto:
          • David Cunningham, MD
          • Numero di telefono: 44-20-8661-3156
      • London, England, Regno Unito, EC1A 7BE
        • Reclutamento
        • Saint Bartholomew's Hospital
      • London, England, Regno Unito, W6 8RF
        • Reclutamento
        • Charing Cross Hospital
        • Contatto:
      • London, England, Regno Unito, NW3 2PF
        • Reclutamento
        • UCL Cancer Institute
        • Contatto:
      • Merseyside, England, Regno Unito, CH63 4JY
        • Reclutamento
        • Clatterbridge Centre for Oncology
      • Newport, England, Regno Unito, PO30 5TG
        • Reclutamento
        • St. Mary's Hospital
        • Contatto:
          • Christopher Baughan, MD
          • Numero di telefono: 44-1983-524-081
      • Nottingham, England, Regno Unito, NG5 1PB
        • Reclutamento
        • Cancer Research Centre at Weston Park Hospital
        • Contatto:
          • J. Hornbuckle, MD
          • Numero di telefono: 44-115-969-1169 ext. 47599
      • Poole Dorset, England, Regno Unito, BH15 2JB
        • Reclutamento
        • Dorset Cancer Centre
        • Contatto:
          • Tamas Hickish, MD
          • Numero di telefono: 44-1202-442-532
      • Salisbury, England, Regno Unito, SP2 8BJ
        • Reclutamento
        • Salisbury District Hospital
      • Southampton, England, Regno Unito, SO16 6YD
        • Reclutamento
        • Southampton General Hospital
        • Contatto:
      • Sutton, England, Regno Unito, SM2 5PT
        • Reclutamento
        • Royal Marsden - Surrey
      • Westcliff-On-Sea, England, Regno Unito, SS0 0RY
        • Reclutamento
        • Southend University Hospital NHS Foundation Trust
        • Contatto:
          • Pauline Leonard, MD
          • Numero di telefono: 44-1702-435-555
      • Worthing, England, Regno Unito, BN11 2DH
        • Reclutamento
        • Worthing Hospital
        • Contatto:
          • Andrew Webb, MD
          • Numero di telefono: 44-1903-205-111
    • Wales
      • Cardiff, Wales, Regno Unito, CF14 2TL
        • Reclutamento
        • Velindre Cancer Center at Velindre Hospital
        • Contatto:
          • Timothy Maughan, MD
          • Numero di telefono: 44-2920-316-904
      • Cardiff, Wales, Regno Unito, CF14 4XW
        • Reclutamento
        • University Hospital of Wales
        • Contatto:
          • Timothy Maughan, MD
          • Numero di telefono: 44-2920-316-904

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

DISEASE CHARACTERISTICS:

  • Histologically* or radiologically confirmed primary adenocarcinoma of the colon or rectum

    • Advanced and/or metastatic disease NOTE: *Liver metastases should not be biopsied

  • Must have potentially resectable liver metastases present, as defined by any of the following:

    • Metachronous metastases AND complete resection of the primary tumor without gross or microscopic evidence of residual disease (R0)
    • Synchronous metastases AND R0 resection of the primary tumor > 1 month before study entry
    • Synchronous metastases with sufficient evidence (e.g., by CT scan or diagnostic laparoscopy) that both the primary tumor and the liver metastases can be completely resected during the same procedure and resection of primary tumor can be delayed for 3-4 months
    • Suboptimally resectable disease (i.e., potentially resectable disease with compromise of the resection margins)
  • No detectable extrahepatic tumor that cannot be completely resected
  • Unidimensionally measurable disease
  • No brain metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • WBC ≥ 4,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count > 150,000/mm³
  • Bilirubin ≤ 1.25 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 5 times ULN
  • AST or ALT ≤ 3 times ULN
  • Creatinine clearance > 50 mL/min OR glomerular filtration rate > 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No psychiatric or neurological condition that would preclude study compliance
  • No partial or complete bowel obstruction
  • No preexisting neuropathy > grade 1
  • No other prior or concurrent malignant disease that, in the opinion of the investigator, would preclude study treatment
  • No concurrent severe uncontrolled medical illness (including poorly-controlled angina or myocardial infarction within the past 3 months) that would preclude study treatment
  • No known hypersensitivity reaction to any of the components of the study drugs

PRIOR CONCURRENT THERAPY:

  • No prior systemic chemotherapy for metastatic disease
  • More than 6 months since prior adjuvant chemotherapy comprising fluorouracil, leucovorin calcium, capecitabine, or irinotecan hydrochloride
  • More than 1 month since prior rectal chemoradiotherapy comprising fluorouracil and leucovorin calcium
  • No concurrent contraindicated medication

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
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: OxMdG / IrMdG chemotherapy
OxMdG / IrMdG chemotherapy for 12 weeks Followed by surgery OxMdG / IrMdG chemotherapy for 12 weeks
Droga: fluorouracile
Droga: leucovorin calcio
Procedura: terapia adiuvante
Procedura: terapia neoadiuvante
Droga: oxaliplatino
Procedura: valutazione della qualità della vita
Droga: capecitabina
Altro: studio delle variabili socioeconomiche e demografiche
Sperimentale: OxMdG / IrMdG chemotherapy with cetuximab
OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks Followed by Surgery OxMdG / IrMdG chemotherapy with cetuximab for 12 weeks
Droga: fluorouracile
Droga: leucovorin calcio
Procedura: terapia adiuvante
Procedura: terapia neoadiuvante
Droga: oxaliplatino
Procedura: valutazione della qualità della vita
Droga: capecitabina
Altro: studio delle variabili socioeconomiche e demografiche
Biologico: cetuximab

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Progression-free survival
Lasso di tempo: end of study
end of study

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Sopravvivenza globale
Lasso di tempo: fine dello studio
fine dello studio
Response rate before surgery as assessed by RECIST criteria
Lasso di tempo: end of study
end of study
Pathological resection status
Lasso di tempo: end of study
end of study
Toxicity
Lasso di tempo: end of study
end of study
Quality of life as assessed by the EQ-5D, EORTC QLQ-C30, and EORTC QLQ-LMC21
Lasso di tempo: end of study
end of study
Cost effectiveness
Lasso di tempo: end of study
end of study
Safety
Lasso di tempo: end of study
end of study

Collaboratori e investigatori

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

Sponsor

University of Southampton

Collaboratori

University Hospital Southampton NHS Foundation Trust

Investigatori

  • Cattedra di studio: John N. Primrose, MD, University Hospital Southampton NHS Foundation Trust

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 febbraio 2007

Completamento primario (Anticipato)

1 dicembre 2014

Date di iscrizione allo studio

Primo inviato

4 giugno 2007

Primo inviato che soddisfa i criteri di controllo qualità

4 giugno 2007

Primo Inserito (Stima)

5 giugno 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

23 gennaio 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 gennaio 2013

Ultimo verificato

1 aprile 2008

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CDR0000549541
  • USCTU-4351
  • USCTU-EPOC
  • EUDRACT-2006-003121-82
  • ISRCTN22944367
  • EU-20732

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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Condizioni

Malattie rare

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3
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