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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT01086618
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed colorectal cancer
* Metastases which are unresectable at presentation
* No known unresectable primary tumor on CT/MRI scan
* Primary tumor does not require immediate or emergency intervention including surgery, radiotherapy, laser, or stenting
* Patients who are treated with colonic stents are eligible
* No unequivocal extensive peritoneal metastases
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Must be fit for systemic chemotherapy and surgery
* Hemoglobin \> 10.0 g/dL
* WBC \> 3.0 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Bilirubin \< 25 μmol/L
* GFR \> 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months (female) or up to 2 months (male) after completion of study therapy
* No history of malignant disease within the past 5 years except for nonmelanomatous skin cancer or carcinoma in situ of the cervix
* No serious medical co-morbidity (e.g., uncontrolled inflammatory bowel disease, uncontrolled angina, recent \[within the past 6 months\] myocardial infarction, or another serious medical condition) judged to compromise ability to tolerate chemotherapy and/or surgery
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Concurrent participation in a trial of chemotherapy, if eligible, allowed
* Concurrent short-course radiotherapy for operable rectal cancer allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01086618
Study Brief:
Protocol Section:
NCT01086618