Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer

Study Overview
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Brief Summary
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Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy is recommended for all patients with advanced ovarian cancer. Traditionally, intravenous paclitaxel + carboplatin has been the standard adjuvant therapy. Recently, intraperitoneal combination chemotherapy has been reported to be effective in ovarian cancer. We attempted to evaluate the efficacy and feasibility of standard intravenous paclitaxel + carboplatin plus intraperitoneal paclitaxel chemotherapy.

Detailed Description
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Epithelial ovarian cancer is the leading cause of death from gynecologic malignancies worldwide. The recommended treatment includes primary surgery for diagnosis, staging, and cytoreduction, followed by chemotherapy. Epithelial ovarian cancer is more sensitive to cytotoxic drugs than other solid tumors, most patients with advanced ovarian cancer are recommended treatment with postoperative adjuvant chemotherapy. The recommended initial chemotherapy is generally platinum and taxane combination given by intravenous infusion every 3 weeks for 6 courses. This treatment resulted in complete remission in about 50% of ovarian cancer patients and pathologic complete response in 25 30% of patients. However most patients with advanced ovarian cancer suffered recurrences after primary treatment, median progression free survival is 15.5-22months, and median overall survival is about 31-44months. As residual ovarian cancer after surgery and initial recurrences are primarily confined to the abdomen, intraperitoneal administration of chemotherapy was proposed several decades ago. In 2006, Armstrong, et al., reported improvement of overall survival in ovarian cancer patient with optimal surgical debulking followed intraperitoneal paclitaxel + cisplatin chemotherapy. The National Cancer Institute (NCI) of the United States recommended to consider intraperitoneal chemotherapy in optimally debulking patients. In Korea, however, there are few studies about postoperative adjuvant intraperitoneal chemotherapy in optimally debulked (residual mass <1cm) advanced ovarian cancer patients. Therefore the investigators tend to evaluate the efficacy and feasibility of postoperative adjuvant intraperitoneal chemotherapy. (standard intravenous paclitaxel+carboplatin plus intraperitoneal paclitaxel chemotherapy)

Official Title
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Phase II Clinical Trial of Intravenous Paclitaxel and Carboplatin Plus Intraperitoneal Paclitaxel as an Adjuvant Chemotherapy in Patients With Optimally Debulked Advanced Epithelial Ovarian Carcinoma

Conditions
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Ovarian Neoplasms

Intervention / Treatment
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* Drug: IP chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age >=20 and <=75 Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, tubal cancer Stage 3 or 4 WBC >= 3500/mm3, ANC >= 1500/mm3, platelet >= 100000/mm3, hemoglobin >= 10 g/dl Serum creatinine <= upper normal limit * 1.25 Total bilirubin <= 1.5mg/mm3, ALT/AST <= upper normal limit * 3, ALP <= upper normal limit * 3 Adequate compliance and geographical closeness which make adequate follow-up possible GOG performance status 0-2 Anticipated survival >= 3 months Who agreed to participate in this study and signed on informed consent form Exclusion criteria: History of chemotherapy or radiotherapy on abdomen/pelvis area Pleural/pericardial effusion, ascites causing respiratory difficulties >= NCI-CTCAE grade 2 History of other cancers within 5 years History of unapproved therapy within 30 days before enrollment Other serious diseases which could threat the safety of participants or impair the ability of participants to complete the participation.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IP Chemotherapy<br>Patients with optimally debulked advanced (stage 3 or 4) epithelial ovarian cancer; IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles | Drug: IP chemotherapy<br>* IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles<br>* Other names: Carboplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 year progression-free survival rate. | The time from randomization to the time of disease progression as determined by the investigator or death from any cause. Progression is diagnosed by imaging or serial tumor marker elevation. | 2 Year after initial surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median overall survival | Median observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol | From entry into the study to 5 year after treatment or until half of participants are dead | 
| 5 year progression-free survival rate | The time from randomization to the time of disease progression as determined by the investigator (by clinical, radiological or pathological means) or death from any cause | 5 year after initial surgery | 
| 5 year overall survival rate | Observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol. | 5 year after initial surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OVARIAN NEOPLASMS, ADJUVANT CHEMOTHERAPY, INTRAPERITONEAL CHEMOTHERAPY