Phase I study for simultaneous radiochemotherapy of relapsed ovarian cancer

Phase 1

Conditions: C51-C58
Malignant neoplasms of female genital organs

Registration Number: DRKS00008552

Lead Sponsor: niversitätsklinikum für Strahlentherapie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting withdrawn before recruiting started

Sex: Female

Target Recruitment: 6

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

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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
determination of the acute toxicity of combined radiochemotherapy according to the Common Toxicity Criteria v. 4.0

Secondary Outcome Measures

Name	Time	Method
- To determine the maximum tolerated dose of complete Abdomen radiation, if possible<br>- Determining whether a second cisplatin chemotherapy course during radiotherapy is possible and if so, in which week