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 @ 2:13 PM
Ignite Modification Date:
2025-12-24 @ 2:13 PM
NCT ID:
NCT02288195
Eligibility Criteria:
Inclusion Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of rectal adenocarcinoma
* Radiologically measurable or clinically evaluable disease
* Tumor location within 12cm from anal verge
* Clinical stage T2N+ or T3-4aNany,M0 Clinical staging should be estimated based on the combination of the following assessments: physical examination by the primary surgeon, CT scan of the chest/abdomen/pelvis, and a pelvic MRI with or without an endorectal ultrasound (ERUS)
* No evidence that tumor is adjacent to (defined as within 2 mm of) the mesorectal fascia on pre-operative MRI
* No tumor causing symptomatic bowel obstruction
* No distant metastasis
PATIENT CHARACTERISTICS:
* ECOG performance status 0, 1
* White Blood Cell (WBC) ≥ 4,000/mm³
* Platelets ≥ 100,000/mm³
* Hemoglobin \> 10.0 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 1.5 times ULN
* Creatinine ≤ 1.5 times ULN
* No co-morbid illnesses or other concurrent disease that, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Exclusion Criteria:
* Pregnant or nursing
* Patient of child-bearing potential is not willing to employ adequate contraception
* Not willing to return to enrolling medical site for all study assessments
* With other invasive malignancy ≤ 5 years prior to registration; exceptions are colonic polyps, non-melanoma skin cancer, or carcinoma-in-situ of the cervix
* Chemotherapy within 5 years prior to registration (hormonal therapy is allowable if the disease-free interval is ≥ 5 years)
* Prior pelvic radiation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02288195
Study Brief:
Protocol Section:
NCT02288195