Anal CancerPhase 3NCT00025090
Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer
A Phase 3 study testing cisplatin, fluorouracil and mitomycin C in people with Anal Cancer, run by University College London (UCL) Cancer Institute at 13 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anal Cancer
- What is being tested?
- cisplatin, fluorouracil and mitomycin C
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- Mar 2001to Aug 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United Kingdom13 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Northwick Park Hospital
Harrow, England, HA1 3UJ
Ipswich Hospital
Ipswich, England, IP4 5PD
Cookridge Hospital
Leeds, England, LS16 6QB
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Cancer Research UK and University College London Cancer Trials Centre
London, England, NW1 2ND
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Nottingham City Hospital
Nottingham, England, NG5 1PB
Cancer Research Centre at Weston Park Hospital
Sheffield, S1O 2SJ
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Anal Cancer
- Being tested
- cisplatin, fluorouracil, mitomycin C, radiation therapy
- Keywords
- stage I anal cancer, stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, squamous cell carcinoma of the anus, cloacogenic carcinoma of the anus, basaloid carcinoma of the anus
- Medical subject headings
- Anus Neoplasms, Anal Canal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
fluorouracilDrug
mitomycin CDrug
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate at 6 months
Acute toxicity as measured up to 4 weeks after chemoradiation
Recurrence-free survival
Secondary outcomes (3)
Colostomy rate
In field recurrence rate as measured by confirmed disease within radiation therapy field
Cause-specific and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2001
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London (UCL) Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Roger D. James, MD, Study chair, Maidstone Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025090
- Sponsor's protocol ID
- CDR0000068911
- Other IDs
- NCRI-ACT-II, EU-20056, UKCCCR-ACT-II, ISRCTN26715889
- Status last verified
- Mar 2007
- First submitted
- 11 Oct 2001
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer
- ClinicalTrials.gov ID
- NCT00025090
- Acronym / sponsor ID
- CDR0000068911
- Conditions
- Anal Cancer
- Keywords
- stage I anal cancer, stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, squamous cell carcinoma of the anus, cloacogenic carcinoma of the anus, basaloid carcinoma of the anus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University College London (UCL) Cancer InstituteUniversity, hospital or other
- Study start
- Mar 2001
- Study completion
- Aug 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin | Drug | – |
| fluorouracil | Drug | – |
| mitomycin C | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Complete response rate at 6 months
Acute toxicity as measured up to 4 weeks after chemoradiation
Recurrence-free survival
3 secondary outcomes
Colostomy rate
In field recurrence rate as measured by confirmed disease within radiation therapy field
Cause-specific and overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger D. James, MD study chair
Maidstone Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin, fluorouracil and mitomycin C in people with Anal Cancer, run by University College London (UCL) Cancer Institute at 13 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate at 6 months. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.