Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Ovarian Cancer

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ajou University
Information provided by (Responsible Party):
Sang-Yoon Park, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01091636
First received: March 23, 2010
Last updated: June 4, 2013
Last verified: June 2013

March 23, 2010
June 4, 2013
March 2010
December 2013   (final data collection date for primary outcome measure)
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.
Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To assess progression free survival rate during 2years after Intraoperative Hyperthermic Intraperitoneal Chemotherapy followed by Intravenous Chemotherapy in Patients with Ovarian Cancer.
Complete list of historical versions of study NCT01091636 on ClinicalTrials.gov Archive Site
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.

Overall survival, quality of life [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

To assess overall response rate and complication after HIPEC during 3years.

To assess quality of life afer HIPEC.

Not Provided
Not Provided
 
Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Ovarian Cancer
The Phase II Study 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.

*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

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Epithelial Ovarian Cancer
Procedure: Hyperthermic Intraperitoneal Chemotherapy
41.5 oC injected into the perfusion cisplatin (75 mg/m2)during 90min
Other Name: Belmont Instrument Corporation
Experimental: HIPEC
Intraoperative Hyperthermic Intraperitoneal Chemotherapy in Patients with Ovarian Cancer
Intervention: Procedure: Hyperthermic Intraperitoneal Chemotherapy
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. Epub 2009 Jan 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
170
December 2017
December 2013   (final data collection date for primary outcome measure)

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
Female
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01091636
NCCCTS-06-222
Yes
Sang-Yoon Park, National Cancer Center, Korea
National Cancer Center, Korea
Ajou University
Principal Investigator: Sang-Yoon Park, MD, Ph.D. National Cancer Center in Korea
National Cancer Center, Korea
June 2013

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