Last updated on June 2020

Tailored Operative or Non-operative Management for Low-risk Rectal Cancer After Intensive Neoadjuvant Treatment

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Rectal Cancer
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age 18 years and 75 years
  • ECOG Performance status 0-1
  • Histologically confirmed diagnosis of adenocarcinoma of the rectum
  • The distance from down verge of tumor to anal-rectal junction (ARJ) 8cm based on MRI, or 12cm based on sigmoidoscopy;
  • Clinical Stage T2 or T3a or T3b and EMVI (-) and N0-1 and CRM (-) based on MRI
  • No evidence of distant metastases
  • No prior pelvic radiation therapy
  • No prior chemotherapy or surgery for rectal cancer
  • No active infections requiring systemic antibiotic treatment
  • ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin 1.5 x ULN, AST 3 x ULN, ALT 3 x ULN.
  • Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.

Exclusion Criteria:

  • Recurrent rectal cancer
  • Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins.
  • Creatinine level greater than 1.5 times the upper limit of normal.
  • Patients who have received prior pelvic radiotherapy.
  • Patients who are unable to undergo an MRI.
  • Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
  • Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
  • Other Anticancer or Experimental Therapy.
  • Women who are pregnant or breast-feeding.
  • Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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