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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT00165568
Eligibility Criteria:
Inclusion Criteria:
* Metastatic colorectal cancer subjects
* Subjects must have at least one non-radiated FDG-glucose avid (as demonstrated by an FDG-glucose PET scan) liver metastasis of at least 2 cm in size.
* Subjects must have never received chemotherapy for metastatic disease; subjects may have received adjuvant chemotherapy for presumed early stage disease if it was completed at least 12 months prior to study entry date
* All subjects must have already consented to an on-label use of a BV and fluorouracil containing first-line chemotherapy regimen (either with irinotecan or oxaliplatin) and must be a candidate for such a therapy as defined by the enrolling investigator and the community standard of care. As such a chemotherapy regimen requires an infusion port, this port should be placed at least two weeks prior to the subject's first dose of bevacizumab.
* Chronological age ≥ 18 years.
* ECOG performance status ≤ 2.
* Life expectancy ≥ 12 weeks.
* Women must not be pregnant or lactating. Both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study.
* Subjects with concurrent malignancy of any site are eligible if the disease is under adequate control.
* All subjects must sign informed consent.
Exclusion Criteria:
* Subjects in "visceral crises", meaning a delay in achieving tumor response by 2 weeks may result in organ failure, are ineligible for this study.
* Subjects who are planned to undergo treatment with fluorouracil and bevacizumab alone (without irinotecan or oxaliplatin) are ineligible for this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00165568
Study Brief:
Protocol Section:
NCT00165568