Phase 2
N=63
Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer
Anal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00423293 ↗Enrolled (actual)
63
Serious AEs
11.5%
Results posted
May 2013
Primary outcome: Primary: Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events) — 77 percentage of participants — p=0.50
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fluorouracil (Drug); mitomycin C (Drug); Intensity-modulated radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Acute Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events) |
77 | 0.50 |
| SECONDARY Number of Patients With Major Radiation Planning Deviations |
— | — |
| SECONDARY Percentage of Subjects With Acute Adverse Events (AE) |
73; 15; 73; 75; 94; 83 | 0.5 |
| SECONDARY Percentage of Subjects With Late Adverse Events (AE) |
35; 67; 75; 20 | — |
| SECONDARY Clinical Complete Response Rate |
64; 81 | — |
| SECONDARY Duration of Radiotherapy Treatment |
43 | — |
| SECONDARY Five-year Rate of Overall Survival |
76 | — |
| SECONDARY Five-year Rate of Disease-free Survival |
70 | — |
| SECONDARY Five-Year Cumulative Incidence Rate of Local-regional Failure |
16 | — |
| SECONDARY Five-Year Cumulative Incidence Rate of Distant Failure |
16 | — |
| SECONDARY Five-Year Cumulative Incidence Rate of Colostomy Failure |
10 | — |
| SECONDARY Five-Year Rate of Colostomy-free Survival |
74 | — |
Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with 5-fluorouracil (5-FU) and mitomycin C may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving intensity-modulated radiation therapy together with fluorouracil and mitomycin C works in treating patients with invasive anal cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed carcinoma of the anal canal, including any of the following subtypes:
- 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
PATIENT CHARACTERISTICS:
- 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 cancer
- 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
PRIOR CONCURRENT THERAPY:
- 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
Data sourced from ClinicalTrials.gov (NCT00423293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.