NCT01091636

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

9.9 years

First QC Date

March 23, 2010

Last Update Submit

February 12, 2020

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (1)

  • Overall survival, quality of life

    3 years

Study Arms (2)

HIPEC

EXPERIMENTAL

Intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients with Ovarian Cancer after primary cytoreductive surgery or interval cytoreductive surgery

Procedure: Hyperthermic Intraperitoneal Chemotherapy

No HIPEC

NO INTERVENTION

Primary cytoreductive surgery or interval cytoreductive surgery

Interventions

Hyperthermic Intraperitoneal ChemotherapyPROCEDURE

41.5 oC injected into the perfusion cisplatin (75 mg/m2)during 90min

Also known as: Belmont Instrument Corporation
HIPEC

Eligibility Criteria

AgeUp to 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 19169758RESULT

  • Kim JH, Chun SY, Lee DE, Woo YH, Chang SJ, Park SY, Chang YJ, Lim MC. Cost-effectiveness of hyperthermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III-IV ovarian cancer from a randomized controlled phase III trial in Korea (KOV-HIPEC-01). Gynecol Oncol. 2023 Mar;170:19-24. doi: 10.1016/j.ygyno.2022.12.021. Epub 2023 Jan 4.

    PMID: 36608383DERIVED

  • 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.

    PMID: 35712968DERIVED

  • 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.

    PMID: 35262624DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Officials

  • Sang-Yoon Park, MD, Ph.D.

    National Cancer Center in Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Blinded to the participants
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: HIPEC vs. no HIPEC after primary cytoreductive surgery or interval cytoreductive surgery
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynecologic Oncologist, Center for Gynecologic Cancer

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 24, 2010

Study Start

March 1, 2010

Primary Completion

January 10, 2020

Study Completion

January 10, 2020

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

KR(1)