The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.
Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.
5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.
University Hospital Tübingen, Department of Radiation Oncology
Tübingen, Baden-Wurttemberg, Germany
Pathological complete response rate
Time frame: After surgical resection (4-6 weeks after last radiotherapy fraction)
Locoregional progression free survival
Time frame: 3 years
Disease free survival
Time frame: 3 years
Distant metastases free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Number of hyperthermia treatments
Time frame: At completion of hyperthermic radiochemotherapy
Acute and chronic treatment related toxicity, according to CTC criteria
Time frame: 3 years
post operative morbidity
Time frame: 3 years
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