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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025090
First received: October 11, 2001
Last updated: August 23, 2013
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Anal Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: mitomycin C
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Second UK Phase III Anal Cancer Trial: A Trial of Chemoradiation and Maintenance Therapy for Patients With Anal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete response rate at 6 months [ Designated as safety issue: No ]
  • Acute toxicity as measured up to 4 weeks after chemoradiation [ Designated as safety issue: Yes ]
  • Recurrence-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Colostomy rate [ Designated as safety issue: No ]
  • In field recurrence rate as measured by confirmed disease within radiation therapy field [ Designated as safety issue: No ]
  • Cause-specific and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2001
Study Completion Date: August 2007
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025090

Locations
United Kingdom
Northwick Park Hospital
Harrow, England, United Kingdom, HA1 3UJ
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
Cookridge Hospital
Leeds, England, United Kingdom, LS16 6QB
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Cancer Research UK and University College London Cancer Trials Centre
London, England, United Kingdom, NW1 2ND
James Cook University Hospital
Middlesbrough, England, United Kingdom, TS4 3BW
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Nottingham City Hospital
Nottingham, England, United Kingdom, NG5 1PB
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Cancer Research Centre at Weston Park Hospital
Sheffield, United Kingdom, S1O 2SJ
Sponsors and Collaborators
University College London (UCL) Cancer Institute
Investigators
Study Chair: Roger D. James, MD Maidstone Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00025090     History of Changes
Other Study ID Numbers: CDR0000068911, NCRI-ACT-II, EU-20056, UKCCCR-ACT-II, ISRCTN26715889
Study First Received: October 11, 2001
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Anus Neoplasms
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
Mitomycins
Mitomycin
Cisplatin
Fluorouracil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Radiation-Sensitizing Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 28, 2014