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:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00006366
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the distal rectum
* Located 0-9 cm from the dentate line (3-12 cm from the anal verge)
* No extension of malignant disease into the anal canal
* Lesions may be mobile stage T3 by endorectal ultrasound OR fixed, defined as clinical stage T4, by palpation
* No evidence of distant metastases
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC (white blood cell count) greater than 4,000/mm\^3
* Platelet count greater than 130,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal
* Alkaline phosphatase, SGOT (serum glutamic oxaloacetic transaminase), and LDH (lactate dehydrogenase) normal
Renal:
* Creatinine normal
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other invasive malignancy within the past 5 years except:
* Inactive nonmelanomatous skin cancer
* Carcinoma in situ of the cervix
* Synchronous colonic cancer if tumor is Tis or T1 and has been completely resected
* No other serious medical illnesses
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to pelvis
Surgery:
* Not specified
Other:
* No concurrent antiepileptic drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006366
Study Brief:
Protocol Section:
NCT00006366