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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT01899118
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent
2. Age:18-75 years
3. Histologically confirmed locally advanced colorectal cancer (adenocarcinoma)
4. The lower edge of the tumors located below 12 cm from the anal verge
5. Karnofsky Performance Scale ≥70 points, Life expectancy ≥ 6 months
6. No prior chemotherapy was used
7. No history of regional radiation treatment inthe pelvic cavity
8. Adequate hematologic function: Hb ≥ 100 g/L , WBC≥3.5×109, ANC ≥ 1.5×109 /L，PLT ≥ 100×109 /L Adequate renal function: Cr ≤ 1.5×ULN, TB≤2.5 × ULN Adequate hepatic function: ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 2.5×ULN
9. Patients without peripheral neuropathy
Exclusion Criteria:
1. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
2. Rectal cancer patients with concurrent colon cancer
3. Pregnant or lactating women
4. Fertile female patients without using any contraceptives
5. Allergic to cisplatin and fluorouracil
6. Patients with previous peripheral neuropathy
7. Serious complications: myocardial infarction, heart failure (NYHA Classification\>II grade),psychiatric history and severe diabetes
8. Treatment with other anti-cancer therapy(including Chinese herbal medicine)
9. Organ transplant patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01899118
Study Brief:
Protocol Section:
NCT01899118