gms | German Medical Science

Introduction: We present herewith the NOGGO-Trial: “open prospective multicenter feasibility-study with primary concomitant radio chemotherapy consisting of ifosfamide and carboplatin plus external irradiation in locally advanced cervical carcinoma stage IIB and IIIB with curative intention”.

Methods: Entry-Criteria: patients (age 18-70 years) with previously untreated locally advanced cervical cancer stage IIB and IIIB. Patients receive prospectively an external beam irradiation with a total dose of 50.4 Gy in 28 fractions with 1.8 Gy/d according to the ICRU50-report using a linear accelerator of 6 MV in a four-field box technique. Simultaneously three courses of carboplatin AUC 4 day 1 plus ifosfamide 1.2 g/m² for 3 days are administered. Chemotherapy is repeated every 3 weeks beginning at the first day of irradiation. Last chemotherapy is performed in the first week after the last irradiation. There is no prophylactic application of growth factors (G-CSF). In case of leucocytes below 1.5 Gpt/l filgrastim is administered daily up to a level of > 1.5 leucocytes. In case of achieving operability patients undergo radical hysterectomy with lymphadenectomy within 6 weeks after irradiation. If surgery is impossible because of incomplete remission or patients and doctors, respectively reject surgery 3 courses of HDR-Iridium-192-brachytherapy in remote-after-loading-technique with 5 Gy/A for each are given additionally.

Primary objectives: Estimation of remission and toxicity, feasibility of surgery after the whole therapy course. Secondary: 2-year-survival, median progression free time and quality of life.

Conclusions: At time 27 patients are admitted and there is no evidence that chemotherapy and radiotherapy enhance intolerably their toxic effects one another. Additional the following radical surgery is not made more difficult by the regimen. The study is still open and this presentation should be a call for further inclusion of patients.