Trial document




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  DRKS00008552

Trial Description

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Title

Phase I study for simultaneous radiochemotherapy of relapsed ovarian cancer

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Trial Acronym

Ovaradrez

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URL of the Trial

http:///

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Brief Summary in Lay Language

The treatment consists of simultaneous radiation chemotherapy, that means, radiation therapy and chemotherapy are at times simultaneously. The radiation treatment needs in this disease the entire abdominal and pelvic region capture without damaging vital organs like the liver or kidneys. Therefore, it should take place on a relatively new radiation device, the tomotherapy linear accelerator.

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Brief Summary in Scientific Language

In this Phase I study will determine whether simultaneous radiation chemotherapy in relapsed ovarian cancer is tolerable and whether there are initial indications of a dependence of the compatibility of the radiation dose. This combination is examined carefully by the chemotherapy, and radiotherapy. Accordingly, the dosages to be selected both for chemotherapy as well as for radiotherapy.
The TomoTherapy allows radiotherapy of the abdomen while sparing of kidneys, liver and hematopoietic bone marrow.

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Organizational Data

  •   DRKS00008552
  •   2015/05/29
  •   [---]*
  •   yes
  •   Approved
  •   28/15, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1170-1409 
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Health Condition or Problem studied

  •   C51-C58 -  Malignant neoplasms of female genital organs
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Interventions/Observational Groups

  •  

    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 take place the last two weeks. In acute tolerable side effects for
    - Another three patients, the radiation dose of complete abdomen radiation be increased to 20 x 1.2 Gy, with no changes of boost irradiation.
    Simultaneous to the Patientinnenn in the first week of complete abdomen radiation for 5 days 15 mg / m2 body surface area to be treated per day with cisplatin. Repetition of this chemotherapy is - planned in the 4th, 5th or 6th week - depending on the blood count. It is cisplatin instead of in the Ovarialkarzinombehandlung otherwise rather ordinary carboplatin administered as it is a little less myelosuppressive.








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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I
  •   N/A
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Primary Outcome

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

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/10/01
  •   6
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional 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

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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)

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Addresses

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    • Universitätsklinikum für Strahlentherapie
    • Mr.  Prof. Dr. med. Dipl.phys.  Günther  Gademann 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsfrauenklinik
    • Mr.  Prof. Dr. med. Dr. med. h.c.  Serban Dan  Costa 
    • Gerhart-Hauptmann-Str. 35
    • 39108  Magdeburg
    • Germany
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    • Universitätsklinik für Strahlentherapie
    • Mr.  PD Dr. med.  Hans-Joachim  Ochel 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Strahlentherapie
    • Mr.  PD Dr. med.  Hans-Joachim  Ochel 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum für Strahlentherapie
    • Mr.  Prof. Dr. med. Dipl.phys.  Günther  Gademann 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting withdrawn before recruiting started
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.