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Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer

23. august 2013 opdateret af: University College London (UCL) Cancer Institute

Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known if fluorouracil plus radiation therapy is more effective with or without additional chemotherapy in treating anal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus radiation therapy with or without additional chemotherapy in treating patients who have primary anal cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Anal kræft

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Compare the response rates in patients with primary epidermoid anal cancer treated with radiotherapy and fluorouracil with either mitomycin or cisplatin and with or without maintenance therapy.
Compare local control and prevention or delay of disease dissemination in patients treated with these regimens.

OUTLINE: This is randomized, open-label, multicenter study. Patients are randomized to one of four treatment arms.

All patients undergo radiotherapy daily 5 days a week for 5.5 weeks. All patients also receive fluorouracil IV continuously over days 1-4 and 29-32.

Arm I: Patients receive mitomycin IV on day 1.
Arm II: Patients receive cisplatin IV on days 1 and 29.
Arm III: Patients receive mitomycin as in arm I and maintenance therapy comprising fluorouracil IV continuously over days 1-4 and cisplatin IV on day 1 beginning 4-8 weeks after completion of primary therapy and repeating once 3 weeks later.
Arm IV: Patients receive cisplatin as in arm II and maintenance therapy as in arm III.

Patients are followed at 2 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

600

Fase

Fase 3

Kontakter og lokationer

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

Studiesteder

Det Forenede Kongerige
- - Sheffield, Det Forenede Kongerige, S1O 2SJ
    - Cancer Research Centre at Weston Park Hospital
- England
  - Harrow, England, Det Forenede Kongerige, HA1 3UJ
    - Northwick Park Hospital
  - Ipswich, England, Det Forenede Kongerige, IP4 5PD
    - Ipswich Hospital
  - Leeds, England, Det Forenede Kongerige, LS16 6QB
    - Cookridge Hospital
  - London, England, Det Forenede Kongerige, EC1A 7BE
    - Saint Bartholomew's Hospital
  - London, England, Det Forenede Kongerige, NW1 2ND
    - Cancer Research UK and University College London Cancer Trials Centre
  - Middlesbrough, England, Det Forenede Kongerige, TS4 3BW
    - James Cook University Hospital
  - Northwood, England, Det Forenede Kongerige, HA6 2RN
    - Mount Vernon Cancer Centre at Mount Vernon Hospital
  - Nottingham, England, Det Forenede Kongerige, NG5 1PB
    - Nottingham City Hospital
  - Sutton, England, Det Forenede Kongerige, SM2 5PT
    - Royal Marsden - Surrey
  - Westcliff-On-Sea, England, Det Forenede Kongerige, SS0 0RY
    - Southend University Hospital NHS Foundation Trust
- Scotland
  - Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZN
    - Aberdeen Royal Infirmary
- Wales
  - Cardiff, Wales, Det Forenede Kongerige, CF14 2TL
    - Velindre Cancer Center at Velindre Hospital

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

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Histologically confirmed primary epidermoid anal cancer
- Squamous cell
- Basaloid
- Cloacogenic
No adenocarcinoma, malignant melanoma, mucoepidermoid carcinoma, lymphoma, or microinvasive anal intraepithelial neoplasia (without evidence of invasive disease) in the anal canal or margin
No metastatic disease

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

Life expectancy:

Not specified

Hematopoietic:

WBC greater than 3,000/mm^3
Platelet count greater than 100,000/mm^3
Hemoglobin greater than 10 g/dL

Hepatic:

Liver function tests no greater than 2 times normal

Renal:

Glomerular filtration rate at least 50 mL/min

Cardiovascular:

No cardiovascular disease
No uncontrolled angina pectoris
No heart failure
No clinically significant cardiac arrhythmias

Other:

HIV negative
No other significant concurrent illness
Not predominately bed-bound or frail
No severe sepsis
No other prior or concurrent cancer or illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy to pelvis

Surgery:

Not specified

Other:

No prior therapy for anal cancer

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Overlevelse uden gentagelse
Complete response rate at 6 months
Acute toxicity as measured up to 4 weeks after chemoradiation

Sekundære resultatmål

Resultatmål
Colostomy rate
In field recurrence rate as measured by confirmed disease within radiation therapy field
Cause-specific and overall survival

Samarbejdspartnere og efterforskere

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

Sponsor

University College London (UCL) Cancer Institute

Efterforskere

Studiestol: Roger D. James, MD, Maidstone Hospital

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 2001

Studieafslutning (Faktiske)

1. august 2007

Datoer for studieregistrering

Først indsendt

11. oktober 2001

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. august 2013

Sidst verificeret

1. marts 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CDR0000068911
NCRI-ACT-II
EU-20056
UKCCCR-ACT-II
ISRCTN26715889

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