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Follow-Up Study of Patients Who Have Undergone Surgery for Stage I, Stage II, or Stage III Colorectal Cancer

5. august 2011 oppdatert av: University Hospital Southampton NHS Foundation Trust

A Randomised Controlled Trial to Assess the Cost-effectiveness of Intensive Versus no Scheduled Follow-up in Patients Who Have Undergone Resection for Colorectal Cancer With Curative Intent. (FACS - Follow-up After Colorectal Surgery)

RATIONALE: Following patients who have undergone surgery for colorectal cancer may help doctors learn more about the disease and plan better follow-up care.

PURPOSE: This randomized clinical trial is following patients who have undergone surgery for stage I, stage II, or stage III colorectal cancer.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

Primary

  • To assess the effect of augmenting symptomatic follow-up in primary care with two intensive methods of follow-up (monitoring tumor marker in primary care and intensive imaging in hospital) on survival of patients with stage I, II, or III colorectal cancer who have undergone curative resection.

Secondary

  • Determine the quality of life of these patients.
  • Determine the cost of National Health Service (NHS) services utilized.
  • Determine the NHS cost per life-year saved.

OUTLINE: This is a multicenter study. Patients are stratified according to certainty of need for imaging follow-up, as determined by the local clinician (uncertain vs certain). Patients are randomized to 1 of 4 follow-up arms.

  • Arm I (primary care follow-up): Patients undergo symptomatic follow-up (i.e., are asked to contact their physician if they have symptoms suggestive of disease recurrence). Some patients may also undergo a single CT scan 12-18 months post-randomization.
  • Arm II (primary care follow-up): Patients undergo tumor marker measurements (CEA) at baseline, every 3 months for 2 years, and every 6 months for 3 years. Some patients may also undergo a single CT scan 12-18 months post-randomization.
  • Arm III (intensive hospital follow-up): Patients undergo CT scan or MRI at baseline, every 6 months for 2 years, and then annually for 3 years.
  • Arm IV (primary care and intensive hospital follow-up): Patients undergo primary care and intensive hospital follow-up as in arms II (without the single CT scan) and III.

All patients receive a handbook from their physician detailing possible symptoms suggestive of disease recurrence.

Quality of life is assessed at baseline and then annually for 5 years.

Studietype

Observasjonsmessig

Registrering (Forventet)

4760

Kontakter og plasseringer

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

Studiesteder

  • Storbritannia
    • England
      • Burton-upon-Trent, England, Storbritannia, DE13 0RB
        • Rekruttering
        • Queen's Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1283-566-333
      • Carlisle, England, Storbritannia, CA2 7HY
        • Rekruttering
        • Cumberland Infirmary
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1228-523-444
      • Chichester, England, Storbritannia, P019 4SE
        • Rekruttering
        • Saint Richards Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1243-788-122
      • Cosham, England, Storbritannia, PO6 3LY
        • Rekruttering
        • Queen Alexandra Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-23-9228-6710
      • Cottingham, England, Storbritannia, HU16 5JQ
        • Rekruttering
        • Castle Hill Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1482-659-331
      • Crewe, England, Storbritannia, CW1 4QJ
        • Rekruttering
        • Mid Cheshire Hospitals Trust- Leighton Hopsital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1270-255-141
      • Croydon, England, Storbritannia
        • Rekruttering
        • Mayday University Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-20-8401-3000
      • Dartford Kent, England, Storbritannia, DA2 8DA
        • Rekruttering
        • Darent Valley Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1322-428-500
      • Derby, England, Storbritannia, DE22 3NE
        • Rekruttering
        • Royal Derby Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1332-340-131
      • Dudley, England, Storbritannia, DY1 2HQ
        • Rekruttering
        • Russells Hall Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1384-456-111
      • Grantham, Lincolnshire, England, Storbritannia, NG31 8DG
        • Rekruttering
        • Grantham and District Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1476-565-232
      • Harrogate, England, Storbritannia, HG2 7SX
        • Rekruttering
        • Harrogate District Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1423-885-959
      • Harrow, England, Storbritannia, HA1 3UJ
        • Rekruttering
        • St. Mark's Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-20-8235-4000
      • High Wycombe, England, Storbritannia
        • Rekruttering
        • Wycombe General Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1494-426-234
      • Huntingdon, England, Storbritannia, PE18 6NT
        • Rekruttering
        • Hinchingbrooke Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1480-416-416
      • Isleworth, England, Storbritannia, TW7 6AF
        • Rekruttering
        • West Middlesex University Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-20-8560-2121
      • Leeds, England, Storbritannia, LS1 3EX
        • Rekruttering
        • Leeds General Infirmary
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-113-243-2799
      • London, England, Storbritannia, W6 8RF
        • Rekruttering
        • Charing Cross Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-20-8846-1234
      • Maidstone, England, Storbritannia, ME16 9QQ
        • Rekruttering
        • Mid Kent Oncology Centre at Maidstone Hospital
      • Nottingham, England, Storbritannia, NG7 2UH
        • Rekruttering
        • Queen's Medical Centre
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-115-924-9924
      • Plymouth, England, Storbritannia, PL6 8DH
        • Rekruttering
        • Derriford Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-175-277-7111
      • Scarborough, England, Storbritannia, YO12 6QL
        • Rekruttering
        • Scarborough General Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1723-342-175
      • Shrewsbury, England, Storbritannia, SY3 8XQ
        • Rekruttering
        • Royal Shrewsbury Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1743-261-000
      • Slough, Berkshire, England, Storbritannia, SL2 4HL
        • Rekruttering
        • Wexham Park Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1753-634-191
      • Solihull, England, Storbritannia, B91 2JL
        • Rekruttering
        • Solihull Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-121-424-2000
      • Southampton, England, Storbritannia, SO16 6YD
        • Rekruttering
        • Southampton General Hospital
      • Surrey, England, Storbritannia, KT 16 OPZ
        • Rekruttering
        • St. Peter's Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1932-722-233
      • Truro, Cornwall, England, Storbritannia, TR1 3LJ
        • Rekruttering
        • Royal Cornwall Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1872-250-000
      • Uxbridge, England, Storbritannia, UB8 3NN
        • Rekruttering
        • Hillingdon Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1895-238-282
      • Warrington, England, Storbritannia, WA5 1QG
        • Rekruttering
        • Warrington Hospital NHS Trust
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1925-635-911
      • Worcester, England, Storbritannia, WR5 1DD
        • Rekruttering
        • Worcester Royal Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-1905-760-719

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

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Diagnosis of primary colorectal cancer

    • Stage I-III disease

  • Have undergone curative resection (i.e., no residual disease [R0])

    • Microscopically clear margins
  • Complete normal colonic imaging pre-operatively (or post-operatively if unable to view complete colon pre-operatively) by colonoscopy, barium enema, CT pneumocolon, or virtual colonoscopy

  • Post-operative blood CEA ≤ 10 ng/mL (if the normal range is ≤ 5 ng/mL) OR < 2 times upper limit of normal (if normal range is > 5 ng/mL)

    • For patients undergoing adjuvant therapy, CEA should be measured after completion of chemotherapy

  • Has completed primary curative treatment, as deemed by hospital clinician

    • Patients awaiting stoma closure allowed
  • No evidence of metastatic disease on pre- or post-operative liver CT scan (or ultrasound) and chest CT scan (or chest x-ray)
  • No diagnosis of familial adenomatous polyposis (FAP) or dominantly inherited colon cancer

PATIENT CHARACTERISTICS:

  • No concurrent serious illness
  • History of other carcinoma allowed provided primary treatment has been completed, there is no evidence of recurrent disease, and there is no follow-up that conflicts with study follow-up

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Pre-operative radiotherapy or chemoradiotherapy for rectal cancer allowed provided curative resection has been achieved
  • No concurrent participation in a primary treatment clinical trial with conflicting follow-up requirements

Studieplan

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

Hvordan er studiet utformet?

Hva måler studien?

Primære resultatmål

Resultatmål
Overall survival by intention-to-treat analysis

Sekundære resultatmål

Resultatmål
Livskvalitet
Cost of National Health Service (NHS) services utilized
NHS cost per life-year saved

Samarbeidspartnere og etterforskere

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

Sponsor

University Hospital Southampton NHS Foundation Trust

Etterforskere

  • Studiestol: John N. Primrose, MD, University Hospital Southampton NHS Foundation Trust

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. mars 2004

Primær fullføring (Forventet)

1. desember 2013

Datoer for studieregistrering

Først innsendt

16. november 2007

Først innsendt som oppfylte QC-kriteriene

16. november 2007

Først lagt ut (Anslag)

19. november 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. august 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. august 2011

Sist bekreftet

1. august 2009

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000576476
  • USCTU-FACS
  • ISRCTN41458548
  • EU-20788

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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