Fallopian Tube Cancer Clinical Trial
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
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.
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.
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