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

NCT00025090 | Completed Phase 3

• 5 other identifiers: CDR0000068911NCRI-ACT-IIEU-20056UKCCCR-ACT-IIISRCTN26715889
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

cisplatin DRUG

fluorouracil DRUG

mitomycin C DRUG

radiation therapy RADIATION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College London (UCL) Cancer Institute: lead

Study Sites (13)

Northwick Park Hospital

Harrow, England, HA1 3UJ, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Cookridge Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Cancer Research UK and University College London Cancer Trials Centre

London, England, NW1 2ND, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, S1O 2SJ, United Kingdom

Location

MeSH Terms

Conditions

Anus Neoplasms; Anal Canal Carcinoma

Interventions

Cisplatin; Fluorouracil; Mitomycin; Radiotherapy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• Roger D. James, MD

  Maidstone Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 2001
• Study Completion: August 1, 2007
• Last Updated: August 26, 2013

Record last verified: 2007-03

Locations

GB (13)