Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)

The combination of preoperative pelvic RT - either long-course chemoradiotherapy (LCCRT) or short-course radiotherapy (SCRT)- followed by surgery has been the standard of care in the curative treatment of locally advanced adenocarcinoma of the rectum for decades. Some patients however achieve a complete clinical response (cCR) to their preoperative treatment which opens the possibility of avoiding surgery and consequently preserving the rectum. There now exists a growing body of data from centres around the world validating the safety of a surveillance approach in clinical complete responders

Trial Details

NCT ID
NCT06991465
Phase
PHASE2
Sponsor
Neil Kopek
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Radiation Therapy
  • FOLFOX regimen
  • Capecitabine
Locations (sample)
  • Montreal, Quebec, Canada|45.50884,-73.58781

Key Eligibility Criteria

  • Histologically confirmed invasive adenocarcinoma of the rectum
  • Pelvic MRI defined disease (at least one of the following):
  • mesorectum involved or breached - includes involvement of adjacent organ(s) (T3-T4)
  • Patients are considered medically fit for oncologic resection

For full eligibility, visit ClinicalTrials.gov.

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