Neoadjuvant Chemoradiation With 5-FU(or Capecitabine) and Oxaliplatin Combined With Hyperthermia in Rectal Cancer
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
This trial examines the feasibility, effectiveness and safety of a combination of
radiotherapy (over a period of five weeks) and chemotherapy (with 5-FU or Capecitabine and
Oxaliplatin) and 10 fractions of deep regional hyperthermia in patients with primary locally
advanced or locally recurrent rectal cancer. Previous pelvic irradiation in case of a local
recurrence is not excluded from the trial. The treatment protocol aims on a preoperatively
improved tumor regression allowing less aggressive surgery in primary locally advanced rectal
cancer and a higher rate of curative resections in heavily pretreated locally recurrent
rectal cancers.
Primary endpoint of the trial is the feasibility rate of a multimodal regimen consisting of
radiochemotherapy and hyperthermia. Secondary endpoints are local control, survival rates,
and toxicity. It is planned to include a total number of 59 patients over a period of 2.5
years.