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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT00936832
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the rectum
* Lower pole of the tumor \< 12 cm from the anal margin
* Synchronous metastases of the liver and/or lung
* Unresectable or resectability uncertain according to the decision of a local multidisciplinary consultation
* Lesions measurable in 1 dimension by RECIST criteria (metastases and primary rectal cancer)
* No rectal obstruction requiring surgery or the emergency fitting of a prosthesis
* No CNS metastases
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine clearance ≥ 60 mL/min
* Hemoglobin ≥ 10 g/dL (transfusions allowed)
* FEV ≥ 50%
* QT interval ≤ 450 ms (in men) or ≤ 470 ms (in women)
* Total bilirubin ≤ 1.5 times upper limit of normal
* Serum albumin ≥ 25 g/L
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No history of another cancer except for nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
* History of other cancers allowed provided the patient has been disease-free \> 3 years
* None of the following:
* Congestive heart failure or coronary heart disease
* Myocardial infarction within the past year
* Uncontrolled hypertension (systolic BP \> 160 mm Hg or diastolic BP \> 100 mm Hg) despite optimal medical management
* No active severe rectal bleeding
* No liver failure
* No known Gilbert syndrome
* No severe uncontrolled infection
* No chronic diarrhea, malabsorption syndrome, or intestinal obstruction/subocclusion
* No severe uncontrolled pain (visual analogue scale 5/10) with morphine treatment
* No other medical, psychological, or social condition that, in the investigator's opinion, could affect the patient's compliance with study treatment
* No hypersensitivity to any component of study treatment
PRIOR CONCURRENT THERAPY:
* See Patient Characteristics
* No prior radiotherapy to the pelvis
* More than 4 weeks since prior experimental therapy
* More than 7 days since prior CYP3A4 inhibitor before the administration of sunitinib malate
* More than 12 days since prior CYP3A4 inducer
* No concurrent participation in another clinical study
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00936832
Study Brief:
Protocol Section:
NCT00936832