C51-C58
Conditions
Interventions
Group 1:
Radiation therapy for six weeks
- For the first three patients a complete abdomen radiationof 20 x 1.0 Gy is provided in the first four weeks, while a boost irradiation of 10 Gy in 1.5 x to
Sponsors
Universitätsklinikum für Strahlentherapie
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. patient with initial histologically confirmed, abdominally relapsed malignant serous, mucinous or endometrioid ovarian cancer, carcinoma of the tube, or primary peritoneal. 2. platinum-sensitive or platinum-refractory relapse into the peritoneal cavity and simultaneously in subdiaphragmal nearby lymph nodes 3. adequate renal function (calculated GFR> 60 mL / min acc. Cockcroft-Gault formula) and normal liver function (ALT, AST, bilirubin <than 1.5 times the norm) 4. Minimum age 18 years
Exclusion criteria
Exclusion criteria: 1. recurrence surgery promising or necessity of immediate surgery 2. Other malignant neoplasm in history except basal cell carcinoma 3. Karnofsky index below 40% (= disabled, skilled help needed) 4. contrast agent allergy 5. Participation in other clinical study 6. symptomatic adhesions after previous abdominal or pelvic surgery 7. pre-existing bowel disease 8. Clear cell tumor, germ cell tumor, yolk sac tumor or borderline tumor of the ovary 9. inability arms to store high 10. bone marrow dysfunction, thrombocytopenia, leukopenia 11 serious multimorbidity 12. bleeding 13.extraabdominelle distant metastases, liver metastases 14. relevant renal or hepatic impairment 15. application of bevacizumab in the past 4 weeks (because of the associated risk of bowel perforation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| determination of the acute toxicity of combined radiochemotherapy according to the Common Toxicity Criteria v. 4.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine the maximum tolerated dose of complete Abdomen radiation, if possible - Determining whether a second cisplatin chemotherapy course during radiotherapy is possible and if so, in which week | — |
Countries
Germany
Contacts
Public ContactHans-Joachim Ochel
Universitätsklinik für Strahlentherapie
Outcome results
None listed