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A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal

Phase 2
18 Years
Open (Enrolling)
Anal Cancer

Thank you

Trial Information

A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal



- Determine if dose-painted, intensity-modulated radiation therapy (IMRT), fluorouracil,
and mitomycin C decreases the combined rate of gastrointestinal and genitourinary
adverse events (grade II or greater) by at least 15% in the first 90 days after the
start of treatment in patients with primary invasive carcinoma of the anal canal
compared to patients treated on the radiotherapy, fluorouracil, and mitomycin C arm on
clinical trial RTOG 98-11.


- Determine the feasibility of performing IMRT in these patients in a cooperative group

- Evaluate adverse events experienced by patients treated with this regimen and to
decrease the grade 2 and higher and grade 3 and higher overall adverse event rates by
15% or 20% as compared to the radiotherapy and mitomycin C arm of RTOG 98-11.

- Evaluate the total duration of radiotherapy.

- Evaluate the efficacy of this regimen, in terms of locoregional failure, disease-free
survival, time to colostomy, colostomy-free survival, and overall survival of these

- Determine clinical complete response at 8 weeks after completion of study treatment.

OUTLINE: This is a multicenter study.

Patients receive mitomycin C IV over 10-30 minutes on days 1 and 29 and fluorouracil IV
continuously over 96 hours on days 1-4 and 29-32. Patients also undergo dose-painted
intensity-modulated radiation therapy once daily, 5 days a week, for 5½ to 6 weeks beginning
on day 1. Treatment continues in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 59 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed carcinoma of the anal canal, including any of the following

- Squamous cell

- Basaloid

- Cloacogenic

- Primary invasive disease

- T2-4, N0-3 disease

- Clinically positive small inguinal nodes (i.e., < 1 cm in size) must be
confirmed by biopsy (preferably fine-needle aspiration) within the past 6 weeks

- Biopsy is not required for enlarged inguinal, perirectal, or pelvic nodes on
exam or CT scan that are found to be ≥ 1.0 cm and are considered to be
clinically positive


- Zubrod performance status 0-1

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

- ALT and AST < 3 times upper limit of normal

- Absolute neutrophil count ≥ 1,800/mm³

- Serum creatinine ≤ 1.5 mg/dL

- Platelet count ≥ 100,000/mm³

- Bilirubin < 1.4 mg/dL

- WBC ≥ 3,000/mm³

- INR ≤ 1.5

- No known AIDS

- HIV-positive patients without AIDS are eligible

- HIV test required for patients with clinical suspicion of AIDS

- No other invasive malignancy within the past 3 years except for nonmelanomatous skin

- No severe, active comorbidity, defined as any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring IV antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study treatment

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Uncontrolled diabetes mellitus, uncompensated heart disease, and/or uncontrolled
high blood pressure, that in the opinion of the patient's treating physician,
requires an immediate change in management

- Patients may be eligible if appropriate changes in management have resulted
in adequate control of the above mentioned conditions

- Other immunocompromised status (e.g., organ transplantation or chronic
glucocorticoid use)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


- See Disease Characteristics

- No prior radiation therapy to the pelvis that would result in overlap of radiation
therapy fields

- No prior systemic chemotherapy for cancer of the anus

- No prior surgery for cancer of the anus that removed all macroscopic anal cancer

- No concurrent sargramostim (GM-CSF)

- No concurrent amifostine

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)

Outcome Time Frame:

From the start of treatment to 90 days

Safety Issue:


Principal Investigator

Lisa A. Kachnic, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Boston Medical Center


United States: Federal Government

Study ID:




Start Date:

December 2006

Completion Date:

Related Keywords:

  • Anal Cancer
  • stage II anal cancer
  • stage IIIA anal cancer
  • stage IIIB anal cancer
  • basaloid carcinoma of the anus
  • cloacogenic carcinoma of the anus
  • squamous cell carcinoma of the anus
  • Anus Neoplasms



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