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This is an open-label, pilot study in patients with a diagnosis of primary ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adjuvant chemotherapy. It is expected that this first surgery was optimal - as defined as no residual tumor > or = 1 centimeter. Patient has clinical evidence of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate) is heated and administered into the abdomen, followed by hyperthermic intraperitoneal chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for up to 6 cycles.
- The primary objectives are
- to determine the clinical response of hyperthermic intraperitoneal chemotherapy (HIPC) in patients at the time of first clinical recurrence of ovarian, fallopian tube, or primary peritoneal carcinoma
- to determine the feasibility of delivering HIPC in a recurrent setting.
- Secondary objectives are
- to determine disease free survival (DFS) and overall survival (OS),
- to determine treatment related changes in quality of life (QOL)
- to monitor the toxicities and complications associated with HIPC.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hyperthermic intraperitoneal chemotherapy with Carboplatin, Isotonic saline (perfusate), Surgery, Carboplatin, Paclitaxel
Masonic Cancer Center, University of Minnesota
Not yet recruiting
Masonic Cancer Center, University of Minnesota
Published on BioPortfolio: 2014-08-27T03:12:54-0400
This randomized phase II trial studies hyperthermic intraperitoneal chemotherapy or intraperitoneal chemotherapy in improving quality of life in patients with stage IIIC-IV ovarian, fallop...
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Drug treatment designed to further diminish the disease toward complete remission following INDUCTION CHEMOTHERAPY. It helps to consolidate the gains during induction chemotherapy and may be followed by MAINTENANCE CHEMOTHERAPY.
Treatment designed to help prevent a relapse of a disease following the successful primary treatments (INDUCTION CHEMOTHERAPY and CONSOLIDATION CHEMOTHERAPY) with a long-term low-dose drug therapy.
Initial drug treatment designed to bring about REMISSION INDUCTION. It is typically a short-term and high-dose drug treatment that is followed by CONSOLIDATION CHEMOTHERAPY and then MAINTENANCE CHEMOTHERAPY.
A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.
A family of gram-negative, moderately halophilic bacteria in the order Oceanospirillales. Members of the family have been isolated from temperate and Antarctic saline lakes, solar salt facilities, saline soils, and marine environments.
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