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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00070434
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary adenocarcinoma of the rectum
* Locally advanced disease (clinical T3-4, N0-2, M0) based on at least 1 of the following criteria:
* Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall and/or sacrum
* Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane is considered evidence of fixation
* Hydronephrosis on CT scan or intravenous pyelogram of ureteric or bladder invasion by cystoscopy and cytology or biopsy
* Invasion into the prostate, vagina, or uterus
* Transmural penetration of tumor through the muscularis propria as evidenced by CT scan or MRI and endorectal ultrasound
* Distal border of the tumor must be at or below the peritoneal reflection (within 12 cm of the anal verge) by proctoscopic examination
* Measurable disease by x-ray, scans, or physical examination
* Available tumor tissue to determine molecular profile of the tumor before study treatment
* No clinical evidence of high-grade (lumen diameter \< 1 cm) large bowel obstruction unless a diverting colostomy has been performed
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,500/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT or SGPT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* See Disease Characteristics
* Creatinine ≤ 1.5 times ULN OR
* Estimated creatinine clearance \> 50 mL/min
Cardiovascular
* No significant cardiac disease
* No recent myocardial infarction
Gastrointestinal
* See Disease Characteristics
* Able to swallow oral medication
* No active inflammatory bowel disease
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No prior unanticipated severe reaction to study drugs
* No known dihydropyrimidine dehydrogenase deficiency
* No serious uncontrolled infection
* No other serious medical illness that would preclude study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for colon or rectal cancer
Endocrine therapy
* Not specified
Radiotherapy
* No prior pelvic radiotherapy
* No prior intra-operative radiotherapy or brachytherapy
* No concurrent intra-operative radiotherapy or brachytherapy
* No concurrent intensity-modulated radiotherapy
Surgery
* See Disease Characteristics
* See Radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00070434
Study Brief:
Protocol Section:
NCT00070434