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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT00819559
Eligibility Criteria:
Inclusion Criteria:
* Histologically demonstrated and cytologically evident rectal cancer (Glandular carcinoma: located on 4-12cm from anus), the case without remote metastasis
* Age: 18-70 years old
* The patients who did not undergo radiation therapy, surgery or antitumor agent therapy with the same disease medical history
* The patients with clinical stage of T3N0 identified by ultrasound or MRI
* Appropriate bone marrow, liver and renal function as follow; granulocyte ≥ 1500, platelet ≥ 80,000, bilirubin \< 1.5 mg/dl , Serum Creatinine \< 1.5 mg/dl, BUN \< 30,
* The patients who understood the rights to withdraw the agreement at any time and signed on the informed consent form with or without their legal representatives.
Exclusion Criteria:
* Remote metastatic disease
* When the patient is concerned about the local recurrence if the preoperative chemo-radiation therapy is not undergone, or when the patient expects that the possibility of conservation of sphincter is improved owing to the preoperative chemo-radiotherapy.
* Pregnancy
* Radiotherapy, the past history of operation or chemotherapy
* Familial multiple polyp
* Uncontrolled psychiatric disorder, chronic alcohol disease or drug addiction and CNS(Central Nervous System) disorder
* Other malignant disorder
* After the radiotherapy or the case which remote metastasis is detected during the surgery
* The case which has splanchnemphraxis or the risk of progression to occlusion during the examination period
* Those patients who do not agree to participate in this study
* The patients who seemed to be likely to stop in the middle of clinical study.
* The patients who cannot undergo the regular follow-up owing to the following reasons. For instance, the patients who have psychologic, social, family or geographic reason or the patients who have difficulties in observing proper follow-up or clinical examination plan. Also, the patient who the doctor considers them as improper subjects of this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00819559
Study Brief:
Protocol Section:
NCT00819559