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The Phase II Study of Intraoperative Hyperthermic Intraperitoneal Chemotherapy Followed by Intravenous Chemotherapy in Patients With Ovarian Cancer


Phase 2/Phase 3
N/A
75 Years
Open (Enrolling by invite only)
Female
Epithelial Ovarian Cancer

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Trial Information

The Phase II Study of Intraoperative Hyperthermic Intraperitoneal Chemotherapy Followed by Intravenous Chemotherapy in Patients With Ovarian Cancer


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Description:

To assess progression free survival rate during 2 years after Intraoperative Hyperthermic Intraperitoneal Chemotherapy followed by Intravenous Chemotherapy in Patients with Ovarian Cancer.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Sang-Yoon Park, MD, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center in Korea

Authority:

Korea: Institutional Review Board

Study ID:

NCCCTS-06-222

NCT ID:

NCT01091636

Start Date:

March 2010

Completion Date:

December 2017

Related Keywords:

  • Epithelial Ovarian Cancer
  • Fever
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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