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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT01271192
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Adenocarcinoma of the rectum
2. Age:18-80 years old
3. Received curative resection when diagnosed as rectal cancer
4. Local recurrence happened \>6 months after operation,without distant metastasis
5. Local recurrent mass is resectable confirmed by surgeon and radiologist 6.15 days prior recruit, meet the following criteria:
* Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hepatic
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2 times ULN
* AST ≤ 2.5 times ULN
* ALT ≤ 2.5 times ULN
* No hepatic disease that would preclude study treatment or follow-up
* No uncontrolled coagulopathy
* Renal
* Creatinine clearance \> 50 mL/min
* No renal disease that would preclude study treatment or follow-up
7.ECOG status: 0～1
Exclusion Criteria:
1. Other rectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
2. Synchronous colon cancer
3. Hypersensitivity to fluorouracil
4. No More than 4 weeks since prior participation in any investigational drug study
5. Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
6. History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception
7. Uncontrolled hypertension
8. Cardiovascular disease that would preclude study treatment or follow-up
9. Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
10. Pregnant or nursing, Fertile patients do not use effective contraception
11. Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
12. No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01271192
Study Brief:
Protocol Section:
NCT01271192