Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT00423293
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00423293
Study Brief:
Protocol Section:
NCT00423293