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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT00023751
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the rectum
* T1 or T2 by physical and endoscopic exams
* No T3 lesions by clinical or radiological exam
* Villous adenomas or in situ carcinoma allowed without histologicalconfirmation if clinical appearance of cancer
* No multi-focal disease within the rectum at time of initial diagnosis
* No non-adenocarcinomatous rectal cancer or anal cancer
* Less than 4 cm at greatest diameter
* Less than 40% of rectal wall circumference involved
* Proximal margin no greater than 8 cm from dentate line
* No tumor fixation to the perirectal tissues regardless of size
* No malignant regional lymph node or distant metastases by clinical exam orradiographical imaging
* No palpable perirectal lymph nodes or nodes larger than 1 cm
* No evidence of malignant perirectal lymph nodes by endorectal ultrasound orendorectal MRI
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* CTC 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 times normal
Renal:
* Creatinine less than 1.8 mg/dL
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior or concurrent malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* No prior surgery for rectal cancer including prior attempts at transanal or transcoccygeal surgical excision with unclear or positive margins
* Prior incision or operative biopsy or colonoscopic removal allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00023751
Study Brief:
Protocol Section:
NCT00023751