SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer
Trial Parameters
Brief Summary
The purpose of this research study is to find out how safe and effective is treating patients with locally advanced rectal cancer (LARC) with chemotherapy first and then follow with radiation therapy to a higher dose than what is usually delivered and see if patients could have complete response and be spared from surgery.
Eligibility Criteria
Inclusion Criteria: 1. Patients with newly diagnosed, biopsy proven, rectal adenocarcinoma. 2. Primary tumor located ≤18 cm from margin verge. 3. Primary tumor either a T3N0 or T1-4 N positive (as defined per pelvic MRI; nodes ≤ 15 mm). 4. ≥ 18 years of age. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 6. Serum liver function tests values within the range of 1.5 x Upper Limit of Normal (within 6 weeks of enrollment). 7. Negative pregnancy test for women of child-bearing potential (within 4 weeks of enrollment). 8. Ability to understand and the willingness to sign a written informed consent document. 9. Patient is assessed by a surgeon, medical oncologist and a radiation oncologist and deemed fit for Total Neoadjuvant ChemoTherapy (TNT) and surgery. Exclusion Criteria: 1. Metastatic disease on initial work up (Chest and abdomen contrast enhanced CT scan). 2. Synchronous cancer found on colonoscopy. 3. Previous history of pelvic radiotherapy. 4. History of concurr