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Epithelial Ovarian CancerPhase 2/3NCT01091636

Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Ovarian Cancer

A Phase 2/3 study testing Hyperthermic Intraperitoneal Chemotherapy in people with Epithelial Ovarian Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 75 years, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
Hyperthermic Intraperitoneal Chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
1 siteSouth Korea
Study dates
Mar 2010to 10 Jan 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 75 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-769

Other trials in South Korea

About this study

Official title: Randomized Trial of Intraoperative Hyperthermic Intraperitoneal Chemotherapy Followed by Intravenous Chemotherapy in Patients With Ovarian Cancer

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.

Read more

*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

Read the 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

Being tested
Hyperthermic Intraperitoneal Chemotherapy
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperthermic Intraperitoneal ChemotherapyProcedure or surgery

    Also called Belmont Instrument Corporation

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

Study groups in NCT01091636
Study groupRoleWhat they receive
HIPECExperimentalIntraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients with Ovarian Cancer after primary cytoreductive surgery or interval cytoreductive surgery
Receives: Procedure: Hyperthermic Intraperitoneal Chemotherapy
No HIPECNo interventionPrimary cytoreductive surgery or interval cytoreductive surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (1)

  1. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completion10 Jan 2020
  4. Study completion10 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
HIPEC vs. no HIPEC after primary cytoreductive surgery or interval cytoreductive surgery
Masking
Single blind
Who is masked
Participant
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01091636
Sponsor's protocol ID
NCCCTS-06-222
Status last verified
Feb 2020
First submitted
23 Mar 2010
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19169758

  • 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.

    PubMed 36608383

  • 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.

    PubMed 35712968

  • 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.

    PubMed 35262624

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Hyperthermic Intraperitoneal Chemotherapy in people with Epithelial Ovarian Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01091636, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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