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Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01091636
Recruitment Status : Unknown
Verified September 2014 by Sang-Yoon Park, National Cancer Center, Korea.
Recruitment status was:  Enrolling by invitation
First Posted : March 24, 2010
Last Update Posted : September 26, 2014
Sponsor:
Collaborator:
Ajou University
Information provided by (Responsible Party):
Sang-Yoon Park, National Cancer Center, Korea

Tracking Information
First Submitted Date  ICMJE March 23, 2010
First Posted Date  ICMJE March 24, 2010
Last Update Posted Date September 26, 2014
Study Start Date  ICMJE March 2010
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
Progression free survival [ Time Frame: 2 years ]
To assess progression free survival rate during 2 years after Intraoperative Hyperthermic Intraperitoneal Chemotherapy followed by Intravenous Chemotherapy in Patients with Ovarian Cancer.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01091636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
Overall survival, quality of life [ Time Frame: 3 years ]
Ovarian cancer patients after HIPEC are observed complication and 3-year survival rate. Ovarian cancer patients after HIPEC are analyzed quality of life.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
Overall survival, quality of life [ Time Frame: 3 years ]
To assess overall response rate and complication after HIPEC during 3years. To assess quality of life afer HIPEC.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Ovarian Cancer
Official Title  ICMJE The Phase II Study of Intraoperative Hyperthermic Intraperitoneal Chemotherapy Followed by Intravenous Chemotherapy in Patients With Ovarian Cancer
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Epithelial Ovarian Cancer
Intervention  ICMJE Procedure: Hyperthermic Intraperitoneal Chemotherapy
41.5 oC injected into the perfusion cisplatin (75 mg/m2)during 90min
Other Name: Belmont Instrument Corporation
Study Arms  ICMJE Experimental: HIPEC
Intraoperative Hyperthermic Intraperitoneal Chemotherapy in Patients with Ovarian Cancer
Intervention: Procedure: Hyperthermic Intraperitoneal Chemotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 4, 2013)
170
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2010)
214
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, thyroid 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
  13. Cancer tissue is not confirmed during surgery after neo-adjuvant chemotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01091636
Other Study ID Numbers  ICMJE NCCCTS-06-222
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang-Yoon Park, National Cancer Center, Korea
Study Sponsor  ICMJE National Cancer Center, Korea
Collaborators  ICMJE Ajou University
Investigators  ICMJE
Principal Investigator: Sang-Yoon Park, MD, Ph.D. National Cancer Center in Korea
PRS Account National Cancer Center, Korea
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP