This is a single arm phase II study of neoadjuvant chemotherapy followed by local excision and post-operative chemoradiotherapy in patients with early stage, low rectal adenocarcinoma. After completion of pre-treatment tests/procedures (including pelvic MRI/ERUS; MRI is mandatory at baseline and other imaging is encouraged) and confirmation of eligibility, systemic therapy with FOLFOX will be administered for 12 weeks. 2 to 4 weeks after the chemotherapy, restaging of the primary tumor will be done to evaluate response to therapy (Pelvic MRI and /or sigmoidoscopy). Patients with disease progression or inadequate response to chemotherapy to allow local excision will continue with evaluation and treatment per the current standard of care (chemoradiation followed by TME). These patients will be considered failures for the primary endpoint of the study. Patients who respond to the neoadjuvant chemotherapy will proceed with local excision (open, TEMS or TAMIS), 6-12 weeks after the completion of neoadjuvant chemotherapy, followed by 5-FU based chemoradiotherapy 4-12 weeks after local excision. Patients with positive margins at the time of local excision will also be treated as per standard of care and will be considered as failures. Number of patients who can undergo successful local excision with this approach will define the success of the strategy. After chemoradiation therapy post local excision, patients will be followed closely every 3 months for the first 3 years and then every 2 months for the next 2 years (history/physical, CEA and pelvic MRI). Patients who are deemed failures for the primary end-point will be followed as per standard of care, off-study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
FOLFOX regimen will be administered for 6 cycles. Each cycle is 14 days followed by restaging, local surgery and concurrent chemo radiation therapy
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
number of patients whose tumor can be resected by local excision with negative margins
Patients who undergo neoadjuvant chemotherapy, and are able to achieve a local excision in early stage lower rectal adenocarcinoma with negative margins
Time frame: 3 months
Number of patients with improved bowel function in patients treated with organ preserving approach for early stage low rectal cancer before and after therapy
Bowel function will be assessed by Bowel Function Index- Functional Assessment of Chronic Illness Therapy (FACIT) version 4 survey to be completed by patients. The survey measures- Physical well-being, social/family well-being, emotional well-being, functional well-being
Time frame: 3 years
Number of patients with improved sexual function treated with organ preserving approach for early stage low rectal cancer before and after therapy
Sexual function in women will be assessed by Female Sexual Function Index (FSFI) 2000 and in men will be assessed by International Index of Erectile Function (IIEF) questionnaire respectively to be completed by patients. The questions ask about the patients' sexual feelings and responses.
Time frame: 3 years
Number of patients with improved health-related quality of life treated with organ preserving approach for early stage low rectal cancer before and after therapy
Quality of life will be assessed by Patient Reported Outcome Measurement Information System-10 (PROMIS-10) questionnaire to be completed by patients. This questionnaire will have 10 questions.PROMIS Global-10 allows each of the individual items to be examined separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health.
Time frame: 3 years
Overall survival (OS) of patients
OS will be assessed from start of treatment for disease that the patient is still alive
Time frame: 5 years
Disease-free survival (DFS) of patients
DFS will be assessed as the length of time that patient survived without any sign of symptoms of that cancer
Time frame: 5 years
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