DRKS00008552
Recruiting
Phase 1
Phase I study for simultaneous radiochemotherapy of relapsed ovarian cancer - Ovaradrez
niversitätsklinikum für Strahlentherapie0 sites6 target enrollmentMay 29, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- C51-C58
- Sponsor
- niversitätsklinikum für Strahlentherapie
- Enrollment
- 6
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •4\. Minimum age 18 years
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
Outcomes
Primary Outcomes
Not specified
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