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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT00006094
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven previously untreated adenocarcinoma of the rectum thatbegins within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy
* Locally advanced disease defined as any of the following:
* Fixed or immovable tumor on physical exam
* T4 disease with invasion of adjacent structures (e.g., pelvic sidewall, sacral pelvis, bladder, or prostate) by CT scan, rectal ultrasound, or MRI
* T3 disease with invasion through the wall of the muscularis propria by transrectal ultrasound, CT scan, or MRI
* No distant metastatic disease
* Performance status - ECOG 0-2
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than upper limit of normal (ULN)
* SGOT/SGPT no greater than 2.5 times ULN
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
* Patients are not considered to have an active second malignancy if they have completed therapy and are at less than 30% risk of relapse
* No prior or concurrent evidence of neuropathy
* No history of allergy to platinum compounds or antiemetics
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior fluorouracil or platinum-based therapy for any malignancy
* No other concurrent chemotherapy
* Hormonal therapy allowed only for non-disease related conditions (e.g., insulin for diabetes) OR intermittently as an antiemetic (e.g., dexamethasone)
* No prior pelvic irradiation
* No concurrent antiretroviral therapy (HAART) for HIV positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006094
Study Brief:
Protocol Section:
NCT00006094