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Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Ovarian Cancer

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sang-Yoon Park, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01091636
First received: March 23, 2010
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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 interiom 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


Condition Intervention Phase
Epithelial Ovarian Cancer
 Procedure: Hyperthermic Intraperitoneal Chemotherapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Phase II Study of Intraoperative Hyperthermic Intraperitoneal Chemotherapy Followed by Intravenous Chemotherapy in Patients With Ovarian Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    Ovarian cancer patients after HIPEC are observed complication and 3-year survival rate.

    Ovarian cancer patients after HIPEC are analyzed quality of life.



Estimated Enrollment: 168
Study Start Date: March 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIPEC
Intraoperative Hyperthermic Intraperitoneal Chemotherapy in Patients with Ovarian Cancer
 Procedure: Hyperthermic Intraperitoneal Chemotherapy
41.5 oC injected into the perfusion cisplatin (75 mg/m2)during 90min
Other Name: Belmont Instrument Corporation

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 interiom 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

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Disease status Primary ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III or more)
  2. Residual tumor < 1cm after completion of cytoreductive surgery
  3. Age < 75 year
  4. Expected survival > 3 months
  5. Performance status: ECOG 0-1
  6. Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3
  7. Adequate renal function Creatinine ≤ 1.5 mg/dl
  8. Adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
  9. Optimal cardiopulmonary function for surgery
  10. Voluntary participation after getting written informed consent.

Exclusion Criteria:

  1. Unresectable extraperitoneal metastasis (brain, bone, lung parenchyme, and supraclavicular lymph node)
  2. Suboptimal debulking (residual tumor > 1cm)
  3. Previous History of other malignancies (except excision of skin cancer)
  4. Serious heart disease or renal failure
  5. Serious cardiopulmonary insufficiency
  6. Uncontrolled infection
  7. Uncontrolled intercurrent disease
  8. Psychogenic disorder
  9. Patients who are suitable candidates by legally
  10. Pregnant or breast-feeding patients
  11. Patients who are unsuitable candidates by doctor's decision
  12. MMMT
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091636

Locations
Korea, Republic of
National Cancer Center
Goyang, Gyeonggi, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Sang-Yoon Park, MD, Ph.D. National Cancer Center in Korea
  More Information

Publications:

Responsible Party: Sang-Yoon Park, Chief , center for Uterine Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01091636     History of Changes
Other Study ID Numbers: NCCCTS-06-222
Study First Received: March 23, 2010
Last Updated: March 14, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Fever
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Body Temperature Changes
Signs and Symptoms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 23, 2013