EUCTR2006-002687-26-DK
Active, not recruiting
Not Applicable
En fase I / II forsøg med intraperitoneal Paclitaxel og Carboplatin efter cytoreduktiv operation som behandling af Patienter med ovarie carcinoma med peritoneal carcinose eller primær peritoneal carcinomatose
Rigshospital, Finsencenter, Afsnit 39940 sites50 target enrollmentAugust 14, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patienter med histologisk påvist primær peritoneal karcinom eller ovarie carcinoma med peritoneal carcinose efter makroskopisk radikal operation (residual disease mindre end 1 cm)
- Sponsor
- Rigshospital, Finsencenter, Afsnit 3994
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologisk eller cytologisk påvist serøs peritoneal carcinomatose
- •\- Ingen systemiske metastaser
- •\- Optimal debulking (residual disease \<1cm)
- •\- ECOG perfomance status \=2
- •\- Sufficient leverfunktion defineret ved:
- •\-Total billerubin \= UNL (øvre normalgrænse)
- •\-ASAT/ALAT\= 1\.5 x UNL
- •\-Basisk fosfatase \= 2,5 x UNL
- •\- Sufficient nyrefunktion defineret ved:
- •\- GFR \= 35 ml/min
Exclusion Criteria
- •\- Patienter der tidligere har fået behandlingsregimer med kemoterapi grundet metastaserende sygdom.
- •\- Insufficient leverfunktion defineret ved:
- •\-Total bilirubin \> UNL
- •\-ASAT/ALAT \> 1,5 x UNL samtidig med alkalisk fosfatase 2,5 x UNL
- •\- Insufficient nyrefunktion defineret ved:
- •\- GFR \< 35 ml/min
- •\- Tidligere alvorlige allergiske reaktioner (f. eks anafylaktisk chok).
- •\- Samtidig anden alvorlig og/eller ledsagende medicinsk tilstand.
- •\- Kronisk inflammatorisk tarmsygdom og/eller tarmobstruktion
- •\- Neutrofile granulocytter \<1,5 x 109
Outcomes
Primary Outcomes
Not specified
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