Organ Preservation in Early Rectal Cancer Patients

Sponsor: Fox Chase Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03548961

This phase II trial evaluates neoadjuvant FOLFOX chemotherapy, local excision, and post-operative chemoradiotherapy in early-stage low rectal adenocarcinoma. Eligible patients undergo 6 cycles of FOLFOX, followed by tumor restaging. Successful local excision and subsequent chemoradiotherapy determine the strategy's success. Regular follow-ups are conducted post-treatment.

Patient Parameters

Program Overview

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.

Eligibility Criteria

Exclusion Criteria

  1. Patients with contraindication to use FOLFOX chemotherapy and pelvic radiation.
  2. Low risk T1 tumors that fulfill all of the following - size<4 cm, lack of lymphovascular invasion and well differentiated histology, are excluded
  3. High risk T3 tumors that fulfill any of the following - circumferential tumor, extension into mesorectal fascia > 5mm, prediction of positive circumferential resection margin, are also excluded.
  4. T4, node positive or advanced rectal adenocarcinoma. Node positivity defined as nodes greater than 1cm in short axis with loss of uniform cortex/fatty hilum
  5. Patients receiving other investigational agents
  6. Patients who have had chemotherapy (for other malignancies) within 3 years prior to registration
  7. Patients with any prior pelvic radiation therapy
  8. Prior malignancies requiring systemic therapy within the last 3 years (as prior therapy can increase toxicity of current chemo regimen, those patients should be excluded).
  9. History of allergic reactions attributed to compound of similar chemical or biologic composition to the agents used in this study
  10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  11. Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with chemotherapeutic drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  12. Pregnant or breast feeding.

Locations

FACILITYZIPCITYSTATE
Fox Chase Cancer Center19111PhiladelphiaPennsylvania

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