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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03970694
Eligibility Criteria:
Inclusion Criteria:
* Histology confirms colonic adenocarcinoma.
* The distance from the lower edge of the tumor to the anal edge is greater than or equal to 15cm (from sigmoid colon to ileocecal region)
* Preoperative staging (Satisfying any one out of four conditions below)
1. Tumor infiltrates through the intestinal wall and adheres to tissues and organs around the colon(T4b), imaging assesses that R0 resection is unachievable.
2. Pericolonic lymph node involvement is closely adjacent to the large abdominal vessels, imaging assesses that lymphadenectomy is difficult.
3. Surgical exploration indicates that R0 resection is not achievable.
4. In initial diagnosis, surgeon evaluates the need for extensive multi-organ combined resection and expected to damage the organs, which would seriously affect the postoperative quality of life.
* No obvious signs of intestinal obstruction, or obstruction has been relieved after proximal enterostomy.
* Preoperative CT/MRI/PET-CT has ruled out distant metastasis.
* Blood and biochemical indexes achieve standard (Satisfying all three conditions below):
1. Routine blood test: WBC\>4000/mm3; PLT\>100000/mm3; Hb\>6g/dl.
2. Liver function: SGOT, SGPT and Bilirubin are less than or equal to 1.5 times normal upper limit.
3. Renal function: Creatinine is less than or equal to 1.5 times normal upper limit.
Exclusion Criteria:
* History: Has colon surgery history; Received chemotherapy or biotherapy in the past 5 years; Received radiotherapy in treatment field.
* Infectious disease: HIV infection history; Active phase chronic hepatitis B or hepatitis C (high copies of virus DNA); Other serious active clinical infection.
* Diagnosed as stage I colon cancer.
* Extraperitoneal distant metastasis is positive in pre-operative stage.
* Dyscrasia or organ decompensation.
* Received radiation therapy in abdominal or pelvic regions.
* Multiple primary cancer.
* Epileptic seizures requiring medical treatment.
* Other malignant tumor history in the past 5 years (except endocervical cancer in situ or skin basal cell carcinoma which had been cured)
* Chronic inflammatory colorectal disease, unrelieved ileus.
* Drug abuse, has medical, psychological or social condition that might affect research results.
* Allergic to research-related drugs.
* Any unstable situation that might endanger patient's safety or compliance.
* Pregnant, lactating woman patient or fertile but lacks adequate contraceptives.
* Refuses to sign informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03970694
Study Brief:
Protocol Section:
NCT03970694