Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer
NCT ID: NCT00025090
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2001-03-31
2007-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cisplatin
fluorouracil
mitomycin C
radiation therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University College London (UCL) Cancer Institute
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roger D. James, MD
Role: STUDY_CHAIR
Maidstone Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northwick Park Hospital
Harrow, England, United Kingdom
Ipswich Hospital
Ipswich, England, United Kingdom
Cookridge Hospital
Leeds, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Cancer Research UK and University College London Cancer Trials Centre
London, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Nottingham City Hospital
Nottingham, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCRI-ACT-II
Identifier Type: -
Identifier Source: secondary_id
EU-20056
Identifier Type: -
Identifier Source: secondary_id
UKCCCR-ACT-II
Identifier Type: -
Identifier Source: secondary_id
ISRCTN26715889
Identifier Type: -
Identifier Source: secondary_id
CDR0000068911
Identifier Type: -
Identifier Source: org_study_id