This clinical trial studies how well blood tests looking at circulating tumor deoxyribonucleic acid (ctDNA) levels work in improving detection of cancer regrowth during watch & wait (WW) surveillance in patients with stage II or III rectal cancer. Rectal cancer is the 3rd most common cancer in both adult males and females in the United States. Stages II and III rectal cancer are routinely and initially treated with a combination of chemotherapy and pelvic radiation therapy called total neoadjuvant therapy (TNT). Rectal cancer patients with a response after TNT may now be given the option to defer definitive surgery and undergo close WW surveillance instead of surgery. This surveillance is conducted over 5 years and includes scheduled imaging and clinical tests/procedures to look for cancer regrowth. ctDNA are fragments of tumor cell DNA that circulate in the patient's bloodstream. ctDNA has been useful in the early detection of various types of cancer regrowth and often plays a role in colorectal cancer treatment decision-making. ctDNA testing may help improve the ability of doctors to identify the ideal rectal cancer patient to elect to WW management and to detect cancer regrowth during WW management as soon as possible.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07292285.
Locations matching your search criteria
United States
Colorado
Aurora
UCHealth University of Colorado HospitalStatus: Approved
Contact: Jon Vogel
Phone: 720-848-2700
PRIMARY OBJECTIVE:
I. Determine if inclusion of ctDNA testing in evaluation and management of stages 2 and 3 rectal cancers will allow clinicians to improve their selection of patients for WW management and to facilitate the detection of cancer regrowth during WW surveillance.
SECONDARY OBJECTIVES:
I. To evaluate tumor specific ctDNA kinetics at multiple timepoints before, during, and after TNT and during WW surveillance and to correlate these ctDNA measurements with radiographic, pathological, and clinical outcomes.
II. To evaluate and assess the relationship of ctDNA levels to oncologic outcomes of patients with rectal cancer being treated with WW management, including disease specific survival, disease free survival, overall survival, and distant metastasis free survival.
III. To correlate ctDNA levels with endoscopic and radiological responses in the setting of complete clinical response (cCR) or near complete clinical response (nCR) to TNT and impact on clinical decision making to pursue WW or operative intervention.
IV. To compare ctDNA levels and oncological outcomes in patients who achieve cCR or nCR to TNT.
V. To evaluate and assess the treatment and oncologic outcomes for patients with local regrowth and/or distant metastasis.
TERTIARY OBJECTIVE:
I. To assess patient and provider perceptions of shared decision-making during treatment planning after the use of ctDNA.
OUTLINE:
Patients undergo blood sample collection for ctDNA testing within 4 weeks of starting standard of care (SOC) TNT, within 1 week of completion of first phase of TNT, after completion of TNT, and at time of initial TNT response assessment. After completion of TNT, patients are assigned to 1 of 3 groups, per standard guidelines.
GROUP I (ROUTINE WW SURVEILLANCE): Patients with cCR after SOC TNT undergo blood sample collection for ctDNA testing on the day of scheduled endoscopic tumor assessment, which occurs every 3-4 months for 2 years. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) on study.
GROUP II (ENHANCED WW SURVEILLANCE): Patients with nCR after SOC TNT undergo blood sample collection for ctDNA testing every 6-8 weeks, at the time of tumor reassessment until cCR or incomplete clinical response (iCR). If nCR becomes a cCR, ctDNA testing occurs as in Routine WW Surveillance above. If nCR becomes iCR, ctDNA testing occurs as in Surgery below. Patients also undergo CT and MRI on study.
GROUP III (SURGERY): Patients with iCR after SOC TNT undergo rectal surgery, as well as blood sample collection for ctDNA testing within 1 week before surgery and within 1 week of first postoperative restaging evaluation.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorJon Vogel
