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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT01613469
Eligibility Criteria:
Inclusion Criteria:
* over 18 years old
* tumor potentially resectable en bloc; tumors tethered or fixed to a structure that can be removed
* clinical/radiological stages T2,T3,or T4, N0-1
* ANC \>1500, PLT\>100,000
* AST and alkaline phosphatase \< 2.5 X ULN
* bilirubin \< 1.5 X ULN
* CrCl \> 50 ml/min using Cockcroft-Gault formula
* KPS \>60
* ECOG Performance Scale 0-2
* No malignancies within previous 5 years other than non-melanoma skin cancer, in-situ cervical cancer, in-situ ductal breast cancer
* no evidence of metastatic disease
Exclusion Criteria:
* initial tumor fixation to pelvic bone or side wide; technically unresectable disease
* any evidence of distant metastasis
* perforation
* obstruction
* hereditary non-polyposis colorectal cancer
* synchronous primary colon carcinomas except T1 lesions
* known dihydropyrimidine dehydrogenase deficiency
* prior radiation therapy to the pelvis
* prior chemotherapy for malignancies
* known existing uncontrolled coagulopathy
* pregnancy or lactation
* women of childbearing potential not using reliable and appropriate contraceptive method
* serious, uncontrolled concurrent infection(s)
* participation in any investigational drug study within 4 weeks preceding the start of study treatment
* clinically significant heart disease
* other serious uncontrolled medical conditions that might compromise study participation (in the investigator's opinion)
* major surgery within 4 weeks prior to the study treatment
* lack of physical integrity of the upper GI tract or malabsorption syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01613469
Study Brief:
Protocol Section:
NCT01613469