Watch and Wait Management on Rectal Cancer Patients Using New Swift Local Therapy (Whistle)

This is an interventional treatment trial for Rectal Cancer Read More

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.