Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Ovarian Cancer
Primary Purpose
Epithelial Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hyperthermic Intraperitoneal Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- Disease status Primary ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III or more)
- Residual tumor < 1cm after completion of cytoreductive surgery
- Age < 75 year
- Expected survival > 3 months
- Performance status: ECOG 0-1
- Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3
- Adequate renal function Creatinine ≤ 1.5 mg/dl
- Adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
- Optimal cardiopulmonary function for surgery
- Voluntary participation after getting written informed consent.
Exclusion Criteria:
- Unresectable extraperitoneal metastasis (brain, bone, lung parenchyme, and supraclavicular lymph node)
- Suboptimal debulking (residual tumor > 1cm)
- Previous History of other malignancies (except excision of skin cancer, thyroid cancer)
- Serious heart disease or renal failure
- Serious cardiopulmonary insufficiency
- Uncontrolled infection
- Uncontrolled intercurrent disease
- Psychogenic disorder
- Patients who are suitable candidates by legally
- Pregnant or breast-feeding patients
- Patients who are unsuitable candidates by doctor's decision
- MMMT
- Cancer tissue is not confirmed during surgery after neo-adjuvant chemotherapy
Sites / Locations
- National Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HIPEC
No HIPEC
Arm Description
Intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients with Ovarian Cancer after primary cytoreductive surgery or interval cytoreductive surgery
Primary cytoreductive surgery or interval cytoreductive surgery
Outcomes
Primary Outcome Measures
Progression free survival
To assess progression free survival rate during 2 years after Intraoperative Hyperthermic Intraperitoneal Chemotherapy followed by Intravenous Chemotherapy in Patients with Ovarian Cancer.
Secondary Outcome Measures
Overall survival, quality of life
Ovarian cancer patients after HIPEC are observed complication and 3-year survival rate.
Ovarian cancer patients after HIPEC are analyzed quality of life.
Full Information
NCT ID
NCT01091636
First Posted
March 23, 2010
Last Updated
February 12, 2020
Sponsor
National Cancer Center, Korea
Collaborators
Ajou University
1. Study Identification
Unique Protocol Identification Number
NCT01091636
Brief Title
Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Ovarian Cancer
Official Title
Randomized Trial of Intraoperative Hyperthermic Intraperitoneal Chemotherapy Followed by Intravenous Chemotherapy in Patients With Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
January 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
Ajou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The current standard treatment for ovarian cancer, tubal cancer, and primary peritoneal cancer is maximal cytoreductive surgery followed by chemotherapy. Recent randomized trials of Gynecologic Oncology Group (GOG) revealed the survival gain in intraperitoneal chemotherapy compared to the intravenous chemotherapy after the optimal cytoreduction in ovarian cancer (GOG#104, GOG#114, GOG#172). Experts attributed such survival gain to the earlier cycles of intraperitoneal chemotherapy when adhesion was minimal from extensive cytoreductive procedures.
Hyperthermia has an anti-cancer activity itself. Especially, hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, the combination of intraperitoneal chemotherapy with hyperthermia theoretically could lead to higher response rate and better survival outcomes.
*HIPEC: hyperthermic intraperitoneal chemotherapy
There will be an interim analysis when 50% of patients are enrolled.
At the interim analysis, a statistical test will be performed. The nominal significance levels will be determined later. The exact nominal significance level will be determined based on the exact number of events at the time of the interim analysis. The Stopping boundaries will be calculated using an O'Brien-Fleming error spending function
Detailed Description
If a patient is allocated to operation to remove ovarian cancer and metastatic disease in the abdomen, this trial could be considered. Before operation, laboratory test results, image result, patient's medical history, and baseline quality of life will be checked and reviewed.
When optimal cytoreduction (residual tumor<1cm) is attained, this HIPEC (hyperthermic intraperitoneal chemotherapy) could be considered. For the primary advanced epithelial ovarian cancer, HIPEC will be performed at random. For the recurrent ovarian cancer, HIPEC will be performed after completion of cytoreductive procedures. Usually, HIPEC takes one and half hours after cytoreductive surgery.
After cytoreductive surgery followed by HIPEC, adjuvant chemotherapy will be added. The cycle of chemotherapy will be determined according to the patients' clinical outcomes. The laboratory test results, image result, patient's medical history, and baseline quality of life will be checked after the operation, during chemotherapy, and after chemotherapy.
Cytoreduction: an operation to remove ovarian cancer and its metastatic disease
There will be an interim analysis when 50% of patients are enrolled.
At the interim analysis, a statistical test will be performed. The nominal significance levels will be determined later. The exact nominal significance level will be determined based on the exact number of events at the time of the interim analysis. The Stopping boundaries will be calculated using an O'Brien-Fleming error spending function
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
HIPEC vs. no HIPEC after primary cytoreductive surgery or interval cytoreductive surgery
Masking
Participant
Masking Description
Blinded to the participants
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIPEC
Arm Type
Experimental
Arm Description
Intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients with Ovarian Cancer after primary cytoreductive surgery or interval cytoreductive surgery
Arm Title
No HIPEC
Arm Type
No Intervention
Arm Description
Primary cytoreductive surgery or interval cytoreductive surgery
Intervention Type
Procedure
Intervention Name(s)
Hyperthermic Intraperitoneal Chemotherapy
Other Intervention Name(s)
Belmont Instrument Corporation
Intervention Description
41.5 oC injected into the perfusion cisplatin (75 mg/m2)during 90min
Primary Outcome Measure Information:
Title
Progression free survival
Description
To assess progression free survival rate during 2 years after Intraoperative Hyperthermic Intraperitoneal Chemotherapy followed by Intravenous Chemotherapy in Patients with Ovarian Cancer.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival, quality of life
Description
Ovarian cancer patients after HIPEC are observed complication and 3-year survival rate.
Ovarian cancer patients after HIPEC are analyzed quality of life.
Time Frame
3 years
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Disease status Primary ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III or more)
Residual tumor < 1cm after completion of cytoreductive surgery
Age < 75 year
Expected survival > 3 months
Performance status: ECOG 0-1
Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3
Adequate renal function Creatinine ≤ 1.5 mg/dl
Adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
Optimal cardiopulmonary function for surgery
Voluntary participation after getting written informed consent.
Exclusion Criteria:
Unresectable extraperitoneal metastasis (brain, bone, lung parenchyme, and supraclavicular lymph node)
Suboptimal debulking (residual tumor > 1cm)
Previous History of other malignancies (except excision of skin cancer, thyroid cancer)
Serious heart disease or renal failure
Serious cardiopulmonary insufficiency
Uncontrolled infection
Uncontrolled intercurrent disease
Psychogenic disorder
Patients who are suitable candidates by legally
Pregnant or breast-feeding patients
Patients who are unsuitable candidates by doctor's decision
MMMT
Cancer tissue is not confirmed during surgery after neo-adjuvant chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Yoon Park, MD, Ph.D.
Organizational Affiliation
National Cancer Center in Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19169758
Citation
Lim MC, Kang S, Choi J, Song YJ, Park S, Seo SS, Park SY. Hyperthermic intraperitoneal chemotherapy after extensive cytoreductive surgery in patients with primary advanced epithelial ovarian cancer: interim analysis of a phase II study. Ann Surg Oncol. 2009 Apr;16(4):993-1000. doi: 10.1245/s10434-008-0299-y. Epub 2009 Jan 24.
Results Reference
result
PubMed Identifier
35712968
Citation
Kim JH, Lee DE, Lee Y, Ha HI, Chang YJ, Chang SJ, Park SY, Lim MC. Quality of life outcomes from the randomized trial of hyperthermic intraperitoneal chemotherapy following cytoreductive surgery for primary ovarian cancer (KOV-HIPEC-01). J Gynecol Oncol. 2022 Jul;33(4):e54. doi: 10.3802/jgo.2022.33.e54. Epub 2022 May 31.
Results Reference
derived
PubMed Identifier
35262624
Citation
Lim MC, Chang SJ, Park B, Yoo HJ, Yoo CW, Nam BH, Park SY; HIPEC for Ovarian Cancer Collaborators. Survival After Hyperthermic Intraperitoneal Chemotherapy and Primary or Interval Cytoreductive Surgery in Ovarian Cancer: A Randomized Clinical Trial. JAMA Surg. 2022 May 1;157(5):374-383. doi: 10.1001/jamasurg.2022.0143.
Results Reference
derived
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Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Ovarian Cancer
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