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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
45 up to 50.4 Gy; daily dose 1,8 Gy, 5 days per weeks
10 sessions, therapeutic time 60 min
250 mg/m\^2/d as continuous i.v. infusion on d1-14, 22-35 (may be preplaced by Capecitabine)
1650 mg/m\^2/d oral intake d1-14, 22-35 (may be replaced by 5-Fluorouracil)
50 mg/m\^2/d as 2-hour bolus infusion on d2, 9, 23, 30
Klinik Bad Trissl, Innere Medizin
Bad Trissl, Germany
RECRUITINGUniversity Hospital
Düsseldorf, Germany
RECRUITINGUniversitätsklinikum Erlangen, Strahlenklinik
Erlangen, Germany
RECRUITINGLMU München, Campus Großhadern, Medizinische Klinik III, Hyperthermie
München, Germany
RECRUITINGSchlossbergklinik
Oberstaufen, Germany
RECRUITINGUniversitätsklinikum Tübingen, Radioonkologie
Tübingen, Germany
RECRUITINGFeasibility rate (i.e. rate of patients not experiencing dose-limiting toxicity [DLT])
Time frame: Participants will be followed for the duration of therapy and for 6 weeks after the last study treatment dose (approximately 11 to 12 weeks)
Number of hyperthermia applications by patient
Time frame: Duration of therapy (approximately 5 to 6 weeks)
Local progression-free survival
Time frame: Participants will be followed for up to 5 years after the end of therapy (Follow up period)
Distant metastasis-free survival
Time frame: Participants will be followed for up to 5 years after the end of therapy (Follow up period)
Overall survival
Time frame: Participants will be followed for up to 5 years after the end of therapy (Follow up period)
Response rate
Time frame: Participants will be followed for up to 5 years after the end of therapy (Follow up period)
Rate of R0-resections
Time frame: Only of participants who are considered as resectable receive surgery in curative intention 4-6 weeks after completion of chemoradiation (results app. after 10 to 12 weeks after start of therapy)
Rate of acute and late toxicity
Time frame: Participants will be followed for up to 5 years after the end of therapy (Follow up period)
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