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Publikacje naukowe

Randomizowane badanie kliniczne - leczenie raka szyjki macicy w stadium IIIB samą radioretapią w porównaniu do radioterapii skojarzonej z hipertermią.

tytuł oryg.: A randomized clinical trial of radiation therapy versus thermoradiotherapy in stage IIIB cervical carcinoma
Wydawnictwo: International Journal of Hyperthermia
Autor główny: Yoko Harima
Pozostali autorzy: K. Nagata, K. Harima, V. V. Ostapenko, Y. Tanaka, S. Sawada
Data: 2000-07-17

DOI: 10.1080/02656730903092018

Język publikacji: angielski

Klasa publikacji: Badanie kliniczne

Randomizowane: TAK

Wieloośrodkowe: NIE

Faza badania klinicznego: B/D

Liczba pacjentów: 40

Rodzaj HT: LRHT Capacitive

Rodzaj HT opis: Hipertermia miejscowa, głęboka, pojemnościowa

Aparatura: Thermotron RF-8

Jednostka chorobowa: Rak szyjki macicy miejscowo zaawansowany

Symbol Jednostki chorobowej: LACC

Stage: IIIB

Typ skojarzenia HT stosowany w badaniu: HT+RT

Rodzaj CT: Nie dotyczy

Abstract. Background: To clarify the role of thermoradiotherapy for FIGO Stage IIIB cervical carcinomas, both the clinical response and survival of patients treated with radio- or thermoradiotherapy were investigated.
Methods: Forty patients with Stage IIIB uterine cervix carcinoma were treated with external beam irradiation to the pelvis, combined with iridium 192 high-dose-rate intracavitary brachytherapy. All patients were divided randomly into the following two groups: the radiotherapy (RT) group of 20 patients, who underwent radiotherapy alone; and the thermoradiotherapy (TRT) group of 20 patients, who underwent three sessions of hyperthermia in addition to radiotherapy.
Findings: The primary endpoint of this study was local complete response and survival. A complete response was achieved in 50% (10 of 20) in the RT group versus 80% (16 of 20) in the TRT group ( p ˆ 0:048). The 3-year overall survival and disease-free survival of the patients who were treated with TRT (58.2 and 63.6%) were better than those of the patients treated with RT (48.1 and 45%), but these diOEerences were not significant. The 3-year local relapse-free survival of the patients who were treated with TRT (79.7%) was significantly better than that of the patients treated with RT (48.5%) ( p ˆ 0:048). TRT, as delivered in this trial,  as well tolerated and did not significantly add to either the relevant clinical acute or long-term toxicity over radiation alone.
Interpretation: TRT resulted in a better treatment response and 3-year local relapse-free survival rate than RT for patients with FIGO Stage IIIB cervical carcinoma..

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