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

Anal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025090
• Other study ID #: CDR0000068911
• Secondary ID: NCRI-ACT-IIEU-20
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2001
• Last updated: August 23, 2013
• Start date: March 2001
• Est. completion date: August 2007

Study information

• Verified date: March 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

• mitomycin C

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Northwick Park Hospital	Harrow	England
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Cookridge Hospital	Leeds	England
United Kingdom	Cancer Research UK and University College London Cancer Trials Centre	London	England
United Kingdom	Saint Bartholomew's Hospital	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	Cancer Research Centre at Weston Park Hospital	Sheffield
United Kingdom	Royal Marsden - Surrey	Sutton	England
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England

Sponsors (1)

Lead Sponsor	Collaborator
University College London (UCL) Cancer Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate at 6 months			No
Primary	Acute toxicity as measured up to 4 weeks after chemoradiation			Yes
Primary	Recurrence-free survival			No
Secondary	Colostomy rate			No
Secondary	In field recurrence rate as measured by confirmed disease within radiation therapy field			No
Secondary	Cause-specific and overall survival			No