Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03717610|
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Recurrent||Procedure: radical surgery with HIPEC||Phase 3|
Ovarian cancer is the leading cause of gynecological cancer mortality; it is in 75% of cases detected at advanced stages. The standard treatment is cytoreductive surgery with removal of macroscopic tumor, and intravenous chemotherapy. Three randomized trials observed survival gain for ovarian cancer patients that received intraperitoneal chemotherapy after the optimal cytoreduction, however catheter-related complications made the procedure not feasible. A "one-time" hyperthermic intraperitoneal chemotherapy, HIPEC, is an established for peritoneal carcinosis in colorectal cancer, and recently two phase III randomised clinical studies observe survival gain also for ovarian cancer patients after surgery with HIPEC.
Here the investigators, plan to investigate the HIPEC procedure following cytoreductive surgery for recurrent ovarian cancer, a progressed disease without any standard treatment established.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Intraoperative Given Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin During a Cytoreductive Surgery in Patients With Recurrent Ovarian, Peritoneal or Fallopian Tube Cancers|
|Actual Study Start Date :||October 4, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: radical surgery with HIPEC
After achieved macroscopically radical surgery, HIPEC procedure will be performed
Procedure: radical surgery with HIPEC
Straight after macroscopic radical cytoreductive surgery, an intraperitoneal hyperthermic perfusion using the open-abdomen technique will be performed with a single dose of cisplatin 100 mg/m2 administered for 90 minutes in the hyperthermic phase (41°C-43°C).
- Treatment-related toxicities [ Time Frame: 3 months after surgery ]Registration of the effects according to NCI CTCAEv4.0 guidelines.
- Assessment of quality of life [ Time Frame: before surgery, and 4 weeks, 3 months and 6 months after surgery ]EORTC C30 quality of life questionnaire
- Assessment of quality of life in relation to ovarian cancer [ Time Frame: before surgery, and 4 weeks, 3 months and 6 months after surgery ]EORTC OV28 quality of life questionnaire
- Assessment of quality of Life in relation to eventually performed intestinal surgery [ Time Frame: before surgery, and 4 weeks, 3 months and 6 months after surgery ]EORTC CR29 quality of life questionnaire
- Morbidity [ Time Frame: 30 days after surgery ]Rate of the high-grade 3 and 4 complications, according to the Clawien-Dindo scale
- Mortality [ Time Frame: 90 days after surgery ]Number of participants with lethal outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717610
|Contact: Marta Lomnytska, MD, PhD||018-611 00 00 ext +firstname.lastname@example.org|
|Uppsala University Hopsital||Recruiting|
|Uppsala, Sweden, 75185|
|Contact: Marta Lomnytska, PhD 018-611 00 00 ext +46 email@example.com|
|Contact: Ilvars Silins, PhD 018-611 00 00 ext +46 firstname.lastname@example.org|
|Sub-Investigator: Wilhelm Graf, Professor|