Organ Preservation in Early Rectal Cancer Patients
Status:
Recruiting
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
Summary
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.