Randomized study to investigate the efficacy of deep regional hyperthermia in patients with anal carcinoma treated by standard radiochemotherapy with MMC and 5-FU.
Pat. with anal carcinoma and treated with standard radiochemotherapy with Mitomycin C and 5-FU will in the experimental arm receive deep regional hyperthermia (6x).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Radiotherapy 55,8 Gy - 59,4 Gy
MMC w1, w5
5-FU w1, w5
Universitaetsklinikum Erlangen, Strahlenklinik
Erlangen, Germany
RECRUITINGImprovement of complete remission
Time frame: 12 weeks after start of treatment
Colostomy-free survival
Time frame: 5 years after start of treatment
locoregional relapse-free survival
Time frame: 5 years after start of treatment
Overall relapse-free survival
Time frame: 5 years after start of treatment
Overall survival
Time frame: 5 years after start of treatment
Response rate
Time frame: 5 years after start of treatment
Rate of acute and late toxicity
Time frame: 5 years after start of treatment
Quality of life
Time frame: 5 years after start of treatment
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6x deep regional hyperthermia