Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	Not specified	Other	NCRI-ACT-II EU-20056, UKCCCR-ACT-II, ISRCTN26715889, NCT00025090

Objectives

1. 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.
2. Compare local control and prevention or delay of disease dissemination in patients treated with these regimens.

Entry 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

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

Patient Characteristics:

Age:

• Not specified

Performance status:

• 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm³
• Platelet count greater than 100,000/mm³
• 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

Expected Enrollment

A total of 600 patients (150 per treatment arm) will be accrued for this study.

Outcomes

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

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

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

Trial Contact Information

Trial Lead Organizations

UCL Cancer Institute

Roger James, MD, Protocol chair		Ph: 44-1622-225-135

United Kingdom
	Sheffield
	Cancer Research Centre at Weston Park Hospital
		Contact Person	Ph:  44-114-226-5000
England
	Harrow
	Northwick Park Hospital
		John M.A. Northover, MS, FRCS	Ph:  44-20-8864-3232
	Ipswich
	Ipswich Hospital
		Tim Podd, MD	Ph:  44-1473-712-233
	Leeds
	Cookridge Hospital
		David Sebag-Montefiore, MBBS, FRCP, FRCR	Ph:  44-113-392-4244
			Email: david.sebag-montefiore@leedsth.nhs.uk
	London
	Cancer Research UK and University College London Cancer Trials Centre
		Jonathan Ledermann, MD	Ph:  44-20-7679-8040
			Email: j.ledermann@ctc.ucl.ac.uk
		Roger James, MD	Ph:  44-0207-679-9898
	Saint Bartholomew's Hospital
		Maurice Slevin, MD	Ph:  44-17-1606-6662
	Middlesbrough
	James Cook University Hospital
		Johannes Van der Voet, MD	Ph:  44-1642-850-850
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		Robert Glynne-Jones, MD	Ph:  44-1923-844-012
			Email: robglynnejones@nhs.net
	Nottingham
	Nottingham City Hospital NHS Trust
		David A.L. Morgan, MB, FRCR	Ph:  44-115-969-1169
			Email: david.morgan@nottingham.ac.uk
	Sutton
	Royal Marsden - Surrey
		David Cunningham, MD	Ph:  44-20-8661-3279
			Email: david.cunningham@rmh.nhs.uk
	Westcliff-On-Sea
	Southend University Hospital NHS Foundation Trust
		Anne Robinson, MD	Ph:  44-1702-221-226
Scotland
	Aberdeen
	Aberdeen Royal Infirmary
		Leslie Samuel, MD	Ph:  44-84-5456-6000
			Email: leslie.samuel@nhs.net
Wales
	Cardiff
	Velindre Cancer Center at Velindre Hospital
		Timothy Maughan, MD	Ph:  44-2920-316-904

Registry Information
Official Title		Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients with Anal Cancer
Trial Start Date		2001-03-26
Registered in ClinicalTrials.gov		NCT00025090
Date Submitted to PDQ		2001-07-17
Information Last Verified		2007-03-27

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