NCT02487849

HIPEC After Secondary Cytoreductive Operation in Patients With Platinum-sensitive Recurrence of Ovarian Carcinoma

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Krankenhaus Barmherzige Schwestern Linz · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Epithelial Ovarian Cancer
• Peritoneal Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
PROCEDURE	HIPEC	secondary cytoreductive operation
DRUG	Carboplatin	Hyperthermal Intraperitoneal Chemotherapy (HIPEC)

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-07-02
• Last updated: 2020-03-04

Locations

1 site across 1 country: Austria