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

Primary Purpose

Anal Cancer

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
cisplatin
fluorouracil
mitomycin C
radiation therapy
Sponsored by
University College London (UCL) Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwick Park Hospital
  • Ipswich Hospital
  • Cookridge Hospital
  • Saint Bartholomew's Hospital
  • Cancer Research UK and University College London Cancer Trials Centre
  • James Cook University Hospital
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Nottingham City Hospital
  • Royal Marsden - Surrey
  • Southend University Hospital NHS Foundation Trust
  • Aberdeen Royal Infirmary
  • Velindre Cancer Center at Velindre Hospital
  • Cancer Research Centre at Weston Park Hospital

Outcomes

Primary Outcome Measures

Complete response rate at 6 months
Acute toxicity as measured up to 4 weeks after chemoradiation
Recurrence-free survival

Secondary Outcome Measures

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

Full Information

First Posted
October 11, 2001
Last Updated
August 23, 2013
Sponsor
University College London (UCL) Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00025090
Brief Title
Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer
Official Title
Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University College London (UCL) Cancer Institute

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
mitomycin C
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Complete response rate at 6 months
Title
Acute toxicity as measured up to 4 weeks after chemoradiation
Title
Recurrence-free survival
Secondary Outcome Measure Information:
Title
Colostomy rate
Title
In field recurrence rate as measured by confirmed disease within radiation therapy field
Title
Cause-specific and overall survival

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger D. James, MD
Organizational Affiliation
Maidstone Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Northwick Park Hospital
City
Harrow
State/Province
England
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Cookridge Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Cancer Research UK and University College London Cancer Trials Centre
City
London
State/Province
England
ZIP/Postal Code
NW1 2ND
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom

12. IPD Sharing Statement

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

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