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Chemotherapy With or Without Surgery in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

23. august 2013 oppdatert av: University College London Hospitals

A Randomized Trial of Initial Surgery in Advanced Asymptomatic Colorectal Cancer Patients Receiving Chemotherapy for Metastatic Disease

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given alone or together with surgery in treating patients with colorectal cancer.

PURPOSE: This randomized phase II/III trial is studying how well chemotherapy works and compares it with surgery followed by chemotherapy in treating patients with metastatic colorectal cancer that can not be removed by surgery.

Studieoversikt

Status

Fullført

Forhold

Tykktarmskreft

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

To determine whether overall survival is improved in patients with asymptomatic, unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I (control arm): Patients receive systemic chemotherapy according to standard local practice. Patients who develop symptoms from their primary tumor receive treatment as required including surgery, if indicated.
Arm II (experimental arm): Patients undergo surgery at the discretion of the surgeon. Beginning 8 weeks after completion of surgery, patients receive chemotherapy according to standard local practice.

Patients complete quality-of-life questionnaires (EQ-5D) at baseline and then periodically during and after completion of study treatment.

After completion of study treatment, patients are followed every 3 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Studietype

Intervensjonell

Registrering (Forventet)

500

Fase

Fase 2
Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Storbritannia
- England
  - London, England, Storbritannia, NW1 2BU
    - University College Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed colorectal cancer
- Metastases which are unresectable at presentation
No known unresectable primary tumor on CT/MRI scan
Primary tumor does not require immediate or emergency intervention including surgery, radiotherapy, laser, or stenting
- Patients who are treated with colonic stents are eligible
No unequivocal extensive peritoneal metastases

PATIENT CHARACTERISTICS:

WHO performance status 0-1
Must be fit for systemic chemotherapy and surgery
Hemoglobin > 10.0 g/dL
WBC > 3.0 x 10^9/L
Platelet count > 100 x 10^9/L
Bilirubin < 25 μmol/L
GFR > 50 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months (female) or up to 2 months (male) after completion of study therapy
No history of malignant disease within the past 5 years except for nonmelanomatous skin cancer or carcinoma in situ of the cervix
No serious medical co-morbidity (e.g., uncontrolled inflammatory bowel disease, uncontrolled angina, recent [within the past 6 months] myocardial infarction, or another serious medical condition) judged to compromise ability to tolerate chemotherapy and/or surgery

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Concurrent participation in a trial of chemotherapy, if eligible, allowed
Concurrent short-course radiotherapy for operable rectal cancer allowed

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert

Hva måler studien?

Primære resultatmål

Resultatmål
Accrual rate in months 10 to 12 (phase II)
Overall survival for ≥ 2 years (phase III)

Sekundære resultatmål

Resultatmål
Livskvalitet (fase III)
Morbidity of surgery (phase II)
Percentage of patients who receive chemotherapy following surgery (must be over 80%) (phase II)
Morbidity of chemotherapy and surgery (phase III)
Economic evaluation (phase III)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University College London Hospitals

Etterforskere

Hovedetterforsker: Austin Obichere, MD, University College London Hospitals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2010

Primær fullføring (Faktiske)

1. januar 2013

Studiet fullført (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først innsendt

12. mars 2010

Først innsendt som oppfylte QC-kriteriene