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 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT02319304
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 years old at diagnosis.
2. ECOG Performance Status 0, 1, or 2.
3. Biopsy-proven diagnosis of rectal adenocarcinoma.
4. Radiographically measurable or clinically evaluable disease by CT scan of chest/abdomen/pelvis with and without contrast ≤ 28 days prior to registration.
5. Clinical AJCC 7th edition stage T2N1M0, T3N0M0 or T3N1M0 based on physical examination, CT scan chest/abdomen/pelvis, and pelvic MRI or endorectal ultrasound.
6. Preoperative proctoscopy confirming tumor extent as no less than 5 cm and no greater than 12 cm from the anal verge.
7. Evaluation by a surgical oncologist, radiation oncologist, and medical oncologist ≤ 28 days prior to registration.
8. Confirmation by a surgeon that the patient is able to undergo a low anterior resection with total mesorectal excision ≤ 28 days prior to registration.
9. In the absence of a being treated on a clinical trial, the patient would be recommended to receive neoadjuvant chemoradiation followed by curative intent surgery.
10. The following laboratory values obtained ≤ 28 days prior to registration:
* Absolute neutrophil count (ANC) ≥ 1500/mm3.
* Platelet count ≥ 100,000/mm3.
* Hemoglobin \> 8.0 g/dL. May transfuse to meet eligibility.
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
* SGOT (AST) ≤ 3 x ULN.
* SGPT (ALT) ≤ 3 x ULN.
* Creatinine ≤ 1.5 x ULN.
11. Negative pregnancy test (B-HCG) within 7 days prior to registration for women of childbearing potential.
12. Did the patient provide study-specific informed consent prior to study entry?
13. Willingness to return to the enrolling medical site for all study assessments.
Exclusion Criteria:
1. Clinical T4 tumor.
2. Primary surgeon indicates the need for an abdominal perineal resection (APR) at baseline.
3. Previous pelvic RT.
4. Autoimmune disease such as scleroderma, lupus, or inflammatory bowel disease.
5. Tumor \< 3 mm from the mesorectal fascia as seen on MRI or endorectal ultrasound.
6. Tumor-induced symptomatic bowel obstruction.
7. Chemotherapy (including hormonal therapy) within the past 5 years from date of registration.
8. Other invasive malignancies within past 5 years from date of registration.
9. Pregnant or nursing women.
10. Men or women of childbearing potential who are unwilling to employ adequate contraception.
11. Other co-morbid conditions that, based on the judgment of the physicians obtaining informed consent, would make the patient inappropriate for this study.
12. Any conditions that would preclude a patient from completing all study assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02319304
Study Brief:
Protocol Section:
NCT02319304