First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer
NCT ID: NCT01669226
Last Updated: 2016-12-19
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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COMPLETED
PHASE2
215 participants
INTERVENTIONAL
2009-04-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Regimen B, PEip and TCiv therapy
Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin
PEip (weekly) and TCiv
IP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
Regimen A: Standard TCiv therapy
IV paclitaxel plus carboplatin or docetaxel plus carboplatin
TCiv
IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
Interventions
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PEip (weekly) and TCiv
IP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
TCiv
IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph node metastasis alone
* Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 1cm
* Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection.
* ECOG performance 0-2.
* No more than 3 cycles of chemotherapy prior to surgery.
* Laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3. Hepatic: bilirubin less than 1.25 times upper limit of normal (ULN); Bilirubin \< 2.0, SGPT less than 2 times ULN. Renal: creatinine less than 1.6 mg/dL, OR creatinine clearance greater than 40 mL/min.
* Comply with intraperitoneal chemotherapy and follow-up.
* Written informed consent.
Exclusion Criteria
* Laboratory testing insufficiency. Hemoglobin \< 10 g/dL. Renal insufficiency with serum creatinine \> 1.6.
* Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count less than 80,000/mm3.
* Active infection.
* Clinically significant gastrointestinal abnormalities.
* Active coronary artery disease, cerebrovascular disease, restrictive or obstructive pulmonary disease, or congestive heart failure.
* Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
* Prior invasive malignancies within the last 5 years showing activity of disease.
18 Years
75 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Zhongshan Hospital
OTHER
Shanghai Gynecologic Oncology Group
OTHER_GOV
Responsible Party
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Principal Investigators
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Rongyu Zang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Gynecologic Oncology Group
Locations
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Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Wuxi Cancer Hospital
Wuxi, Jiangsu, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Fudan University Cancer Hospital
Shanghai, , China
Countries
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References
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Shi T, Jiang R, Pu H, Yang H, Tu D, Dai Z, Cai Y, Zhang Y, Cheng X, Jia H, Tu R, Wang H, Tang J, Luan Y, Cai S, Zang R; SGOG-OV/AICE Investigators. Survival benefits of dose-dense early postoperative intraperitoneal chemotherapy in front-line therapy for advanced ovarian cancer: a randomised controlled study. Br J Cancer. 2019 Aug;121(5):425-428. doi: 10.1038/s41416-019-0543-1. Epub 2019 Aug 6.
Related Links
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Shanghai Gynecologic Oncology Group
Other Identifiers
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SGOG OV1
Identifier Type: OTHER
Identifier Source: secondary_id
V01-2009-03
Identifier Type: -
Identifier Source: org_study_id