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 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT00383695
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma or undifferentiated non-small cell carcinoma of the rectum
* MRI-defined high-risk, operable disease, defined by ≥ 1 of the following:
* Tumors within 1 mm of mesorectal fascia (i.e., circumferential resection margin threatened or involved)
* T3 tumors at or below levators
* Tumors extending ≥ 5 mm into perirectal fat
* T4 tumors
* Presence of extramural venous invasion (primary tumor is therefore at least T3)
* No evidence of metastatic disease by CT scan of the chest and abdomen or, if required, by positron emission tomography scan or biopsy
* No rectal cancer that is unlikely to be operable even after neoadjuvant treatment (i.e., tumor involving the internal iliac vessels)
* No T1-2 rectal cancer, in the absence of other high-risk factors
* T2 tumors within 1 mm of mesorectal fascia allowed
* No recurrent disease
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Life expectancy \> 3 months
* WBC \> 3,000/mm³
* Absolute neutrophil count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* Transaminases \< 2.5 times ULN
* Creatinine normal OR creatinine clearance \> 50 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No concurrent uncontrolled medical condition
* No other active malignant disease within the past 10 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No contraindications to MRI (e.g., pacemaker)
* No medical or psychiatric conditions that would preclude informed consent
* No known malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
* No clinically significant (i.e., active) cardiac disease, including any of the following:
* Congestive heart failure
* Symptomatic coronary artery disease
* Cardiac dysrhythmia (e.g., atrial fibrillation, even if controlled with medication)
* Myocardial infarction within the past 12 months
* No symptoms or history of peripheral neuropathy
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy, radiotherapy, or investigational treatment for rectal cancer
* No other concurrent cytotoxic agents or investigational drugs
* No concurrent sorivudine or sorivudine analogues (e.g., brivudine)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00383695
Study Brief:
Protocol Section:
NCT00383695