Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

5. august 2011 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

4760

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital Southampton NHS Foundation Trust

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2004

Primær færdiggørelse (Forventet)

1. december 2013

Datoer for studieregistrering

Først indsendt

16. november 2007

Først indsendt, der opfyldte QC-kriterier

16. november 2007

Først opslået (Skøn)

19. november 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. august 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2011

Sidst verificeret

1. august 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kolorektal cancer

Kliniske forsøg med computertomografi

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Finland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner