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| Name | Class |
|---|---|
| Uppsala University | OTHER |
| The Netherlands Cancer Institute | OTHER |
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This is a feasibility single-center study to investigate the tolerability, toxicity, quality of life, morbidity, mortality of the HIPEC treatment following cytoreductive surgery for treatment of recurrent ovarian, peritoneal, and fallopian tube cancers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete cytoreductive surgery plus HIPEC with cis-platinum100mg/m2 for 90 min | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radical surgery with HIPEC | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related toxicities | Registration of the effects according to NCI CTCAEv4.0 guidelines. | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of quality of life | EORTC C30 quality of life questionnaire | before surgery, and 4 weeks, 3 months and 6 months after surgery |
| Assessment of quality of life in relation to ovarian cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Lomnytska, MD, PhD | Contact | 018-611 00 00 | +46 | marta.lomnytska@akademiska.se |
| Name | Affiliation | Role |
|---|---|---|
| Marta Lomnytska, MD, PhD | Uppsala University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hopsital | Recruiting | Uppsala | 75185 | Sweden |
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| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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|
EORTC OV28 quality of life questionnaire
| before surgery, and 4 weeks, 3 months and 6 months after surgery |
| Assessment of quality of Life in relation to eventually performed intestinal surgery | EORTC CR29 quality of life questionnaire | before surgery, and 4 weeks, 3 months and 6 months after surgery |
| Morbidity | Rate of the high-grade 3 and 4 complications, according to the Clawien-Dindo scale | 30 days after surgery |
| Mortality | Number of participants with lethal outcome | 90 days after surgery |
| D006979 |
| Hyperthermia, Induced |