This clinical trial compares how well active surveillance versus standard of care surgical management works in treating participants with rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with rectal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03594630.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: George Jae-Shik Chang
Phone: 713-792-6940
PRIMARY OBJECTIVES:
I. To quantify the rate of organ preservation with active surveillance of locally advanced rectal cancer in patients achieving a clinical complete response (cCR) or near complete response (nCR).
SECONDARY OBJECTIVES:
I. To correlate clinical, radiographic, and pathologic findings after neoadjuvant therapy for rectal cancer.
II. To assess oncologic outcomes (e.g., tumor regrowth, distant metastasis, salvage surgery) following active surveillance.
III. To assess knowledge, decision quality, and decision regret for patients with rectal cancer facing multiple treatment options following a cCR/nCR.
IV. To assess rate of and time to circulating tumor deoxyribonucleic acid (ctDNA)-based detection of tumor regrowth or distant metastasis.
CORRELATIVE OBJECTIVES:
I. Obtain tissue to monitor treatment response and future biomarker analyses.
OUTLINE: Participants consult with their surgeon and choose to enroll in 1 of 2 groups.
GROUP I: Participants undergo standard surgical resection and may receive chemotherapy according to the physicians discretion. Participants undergo colonoscopy on study and computed tomography (CT) scan and blood sample collection throughout the study.
GROUP II: Participants receive active surveillance and undergo surgical resection if tumor regrowth is found. Participants undergo colonoscopy on study and endoscopy, magnetic resonance imaging (MRI), CT scan and blood sample collection throughout the study.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorGeorge Jae-Shik Chang
