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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT04336202
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologic diagnosis by proctoscopic biopsy of invasive rectal adenocarcinoma will be considered for entry in this study.
* Patient in whom the diagnosis of invasive rectal cancer has been obtained by incisional biopsy (surgical or endoscopic biopsy) that the majority of the tumor has not been removed .
* The tumor should be either palpable by clinical rectal exam or accessible via a rigid proctoscope, and its proximal border should be located no more than 15 cm from the anal verge.
* Rectal cancer clinically stage as T2-T3 N1+ by MRI or endoscopic ultrasound.
* Tumor of 5 cm or less length, non obstructive
* Patient is not suitable for surgery nor chemotherapy due to medical conditions
* Patient must consent to be in the study and consent form must be signed, witnessed and dated prior to registration .
* Patients must be accessible geographically for follow up.
* Adults older than 18 years of age
Exclusion Criteria:
* Patient with malignant rectal tumors other than adenocarcinoma, i.e, sarcoma, lymphoma, carcinoid, squamous cell, cloacogenic, etc.
* Patient who demonstrate prior to randomization, evidence of free perforation, as manifested by free fluid in the abdomen.
* Patient who are curable by standard of care with either surgery or eligible for the Morpheus study.
* Patient who have received any previous therapy (radiation , chemotherapy) for rectal cancer.
* Patient whose tumor is fixed by clinical examination to surrounding structures, precluding the possibility of adequate surgical resection even with pelvic exenteration.
* Patient with a performance status of 3 or 4.
* Patient with tumor involving the anal canal.
* Patient who are pregnant at the time of randomization.
* Patient with psychiatric or addictive disorders that would preclude obtaining informed consent.
* Patient who have multiple primary tumors involving both the colon and rectum that would preclude them from being classified as having only rectal cancer.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04336202
Study Brief:
Protocol Section:
NCT04336202