HIPEC After Secondary Cytoreductive Operation in Patients With Platinum-sensitive Recurrence of Ovarian Carcinoma (HIPEC)
The combination of optimal cytoreductive operation (according to Desktop II criteria), HIPEC with Carboplatin 800 mg/m² KOF (Körperoberfläche) and following platinum-based systemic chemotherapy should be executed In patients with platinum-sensitive recurrence of ovarian carcinoma. Condition for HIPEC is attainment of optimal cytoreduction (R0) and experts judgement of a complication-free prolongation of narcosis after finishing the surgery. HIPEC will be administered additionally to standard therapy. If HIPEC was executed the number of systemic given platinum-based chemotherapy decreases for one cycle.
This regime should be investigated in terms of safety of performance, quality of life for the patients and consequences for the following systemic chemotherapy.
Epithelial Ovarian Cancer
Fallopian Tube Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasability of an Unique Intraoperative Given Hyperthermal Intraperitoneal Chemotherapy With Carboplatin During a Secondary Cytoreductive Operation in Patients With Platinum-sensitive Recurrence of Ovarian Carcinoma|
- Elevation of side-effects and postoperative complication-rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Observation, classification and graduation of side-effects through NCI Common Terminology Criteria for Adverse Events version 4.03 ["safety issue"]
- Survey of quality of life per EORTC evaluated questionnaires [ Time Frame: 24 months ] [ Designated as safety issue: No ]Using EORTC -QLQ-C30 and EORTC QLQ-OV28, at study initiation, postoperative, before systemic chemotherapy and afterwards
- Recording of PFS (progession free survival) [ Time Frame: 24 months ] [ Designated as safety issue: No ]Recording of PFS (progession free survival) of the patients in a time-span of 24 months [kein "safety issue"]
|Study Start Date:||November 2015|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
If patient is eligible - secondary cytoreductive operation will be followed by HIPEC with 800 mg/m² body surface (KOF) Carboplatin with closed technique.
secondary cytoreductive operation
Other Name: Hyperthermal intraperitoneal ChemotherapyDrug: Carboplatin
Hyperthermal Intraperitoneal Chemotherapy (HIPEC)
Other Name: Carboplatin Accord
In occurence with a platinum-sensitive recurrence of EOC survival can be prolonged by a recurrence-operation, if macroscopical tumor-free status (optimal cytoreductive operation) can be reached in combination with a platinum-based standard-chemotherapy.
Several studies showed that the combination of optimal cytoreductive operation and HIPEC is a secure method of treatment. In comparison to operation and standard-chemotherapy it has a significant positive influence on survival rates. A hyperthermal intraperitoneal chemotherapy with Carboplatin is possible without severe side-effects.
The combination of optimal cytoreductive operation (according to Desktop II criteria), HIPEC with Carboplatin and following platinum-based systemic chemotherapy should be carried out in patients with platinum-sensitive recurrence.
Condition for applying HIPEC is reaching optimal cytoreduction (<0.5 cm visible tumour rest at the end of operation) and according to expert opinion a complicatin-free prolongation of narcosis after finishing the operative intervention. HIPEC is carried out additionally to standard therapy. If it can be carried out, the amount of systemically administered patinum-based chemotherapy is reduced for one cycle.
This regime should be tested on safety in performance, quality of life for patients, and consequences for the following systemic chemotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02487849
|Contact: Verena Unterrichter, Dr.||+43 732 7677 ext email@example.com|
|Contact: Carina Allerstorfer, BSc.||+43 732 7677 ext firstname.lastname@example.org|
|Principal Investigator:||Lukas Hefler, Prim. Dr.||Krankenhaus der Barmherzigen Schwestern Linz|