Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion
NCT ID: NCT03095001
Last Updated: 2017-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2017-06-01
2020-06-01
Brief Summary
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Objective: This study aims to treat malignant peritoneal adhesion with the combination of antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal antiangiogenic agent plus chemotherapy. As explosive endpoints, we will examination the expression of VEGF-A in peritoneal cavity during the treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intraperitoneal bevacizumab+ carboplatin
Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles
Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
Bevacizumab
Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles
Carboplatin
carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles
paclitaxel
paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles
Intraperitoneal carboplatin
Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks
Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles
Carboplatin
carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles
paclitaxel
paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles
Interventions
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Bevacizumab
Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles
Carboplatin
carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles
paclitaxel
paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age of 18-70, Karnofsky score higher than 80.
3. No severe functional damage of major organ, normal liver and kidney function.
4. Peritoneal adhesion. (1) peritoneal adhesions diagnosed by microlaparoscopy or abdominal operations, and classification according to Nair criteria is performed. (1) must be met. (2) Peritoneal adhesion symptoms, intermittent abdominal pain, abdominal distension, nausea and vomiting, hard to pass stools or gas; (3) Peritoneal adhesion signs，abdominal distension, abdominal tenderness, reduced or absent bowel sounds; (4) B ultrasound or CT or MRI show peritoneal adhesion or adhesion-related complications.
Exclusion Criteria
2. Patients known to be allergic to bevacizumab or any of the components of the drug.
3. Other ongoing anti-tumor treatment.
4. Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure
5. Active wound infection and a history of uncontrolled psychiatric illness.
\-
18 Years
70 Years
FEMALE
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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DuNan
Director of oncology
Principal Investigators
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Nan Du, PhD
Role: STUDY_DIRECTOR
PLA 304 hospital
Locations
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First Affiliated Hospital, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Hui Zhao, Phd
Role: primary
References
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Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Other Identifiers
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Intraperitoneal bev
Identifier Type: -
Identifier Source: org_study_id
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