- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00025090
Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer
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
Betingelser
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
Tilmelding (Forventet)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Sheffield, Det Forenede Kongerige, S1O 2SJ
- Cancer Research Centre at Weston Park Hospital
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England
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Harrow, England, Det Forenede Kongerige, HA1 3UJ
- Northwick Park Hospital
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Ipswich, England, Det Forenede Kongerige, IP4 5PD
- Ipswich Hospital
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Leeds, England, Det Forenede Kongerige, LS16 6QB
- Cookridge Hospital
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London, England, Det Forenede Kongerige, EC1A 7BE
- Saint Bartholomew's Hospital
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London, England, Det Forenede Kongerige, NW1 2ND
- Cancer Research UK and University College London Cancer Trials Centre
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Middlesbrough, England, Det Forenede Kongerige, TS4 3BW
- James Cook University Hospital
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Northwood, England, Det Forenede Kongerige, HA6 2RN
- Mount Vernon Cancer Centre at Mount Vernon Hospital
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Nottingham, England, Det Forenede Kongerige, NG5 1PB
- Nottingham City Hospital
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Sutton, England, Det Forenede Kongerige, SM2 5PT
- Royal Marsden - Surrey
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Westcliff-On-Sea, England, Det Forenede Kongerige, SS0 0RY
- Southend University Hospital NHS Foundation Trust
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Scotland
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Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZN
- Aberdeen Royal Infirmary
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Wales
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Cardiff, Wales, Det Forenede Kongerige, CF14 2TL
- Velindre Cancer Center at Velindre Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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:
- 0-2
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Overlevelse uden gentagelse
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Complete response rate at 6 months
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Acute toxicity as measured up to 4 weeks after chemoradiation
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Sekundære resultatmål
Resultatmål |
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Colostomy rate
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In field recurrence rate as measured by confirmed disease within radiation therapy field
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Cause-specific and overall survival
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Roger D. James, MD, Maidstone Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Rektale neoplasmer
- Anus sygdomme
- Anus neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Alkyleringsmidler
- Antibiotika, antineoplastisk
- Fluorouracil
- Mitomyciner
- Mitomycin
Andre undersøgelses-id-numre
- CDR0000068911
- NCRI-ACT-II
- EU-20056
- UKCCCR-ACT-II
- ISRCTN26715889
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 .
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