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| ID | Type | Description | Link |
|---|---|---|---|
| SGOG OV1 | Other Identifier | SGOG |
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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
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The purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.
This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in the first-line therapy for ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen B, PEip and TCiv therapy | Experimental | Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin |
|
| Regimen A: Standard TCiv therapy | Active Comparator | IV paclitaxel plus carboplatin or docetaxel plus carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEip (weekly) and TCiv | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month disease non-progression rate | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | up to 120 months | |
| Completion rate of intraperitoneal chemotherapy. | up to 6 months | |
| Quality of life assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rongyu Zang, MD,PhD | Shanghai Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital Southeast University | Nanjing | Jiangsu | 210009 | China | ||
| Suzhou Municipal Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31383985 | Derived | 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. |
| Label | URL |
|---|---|
| Shanghai Gynecologic Oncology Group | View source |
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|
| TCiv | Drug | IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5 |
|
|
| baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy. |
| Overall Survival | up to 120 months |
| adverse effects | Participants will be followed for the duration of hospital stay, an expected average of 5 weeks |
| Suzhou |
| Jiangsu |
| China |
| Wuxi Cancer Hospital | Wuxi | Jiangsu | China |
| Shanghai Zhongshan Hospital | Shanghai | Shanghai Municipality | 200030 | 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 | 200032 | China |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D010984 | Platinum |
| D005047 | Etoposide |
| C080625 | taxane |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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