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| ID | Type | Description | Link |
|---|---|---|---|
| SGOG OV-05 | Other Identifier | Shanghai Gynecologic Oncology Group |
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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Shanghai Jiao Tong University School of Medicine | OTHER |
| Zhejiang Cancer Hospital | OTHER |
| Sun Yat-sen University |
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This is a Phase II, open-label, multicenter, randomized umbrella study to evaluate the efficacy of cytoreductive surgery and Niraparib maintenance in participants with platinum-sensitive secondary recurrent ovarian cancer. Cohort 1 will focus on participants without prior use of PARP inhibitor, and without prior secondary cytoreduction (SCR) when first recurrence. Cohort 2 will focus on participants with prior use of PARP inhibitor, but without prior SCR when first recurrence. Cohort 3 will focus on participants with SCR when first recurrence, but without prior use of PARP inhibitor.
This exploratory trial is to compare the efficacy of secondary cytoreductive surgery followed by chemotherapy and Niraparib maintenance, versus chemotherapy alone followed by Niraparib maintenance in patients with platinum-sensitive secondary recurrent ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Experimental | Intervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib |
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| No surgery | Active Comparator | Intervention: Drug: Platinum-based chemotherapy and Niraparib |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Tumor debulking surgery (surgery in recurrent ovarian disease) |
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| Measure | Description | Time Frame |
|---|---|---|
| 12-month disease non-progression rate | 12-month non-progression rate | up to 12 months after last patient randomized |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | from date of randomization until the date of 3rd relapse/progression or death (whatever occurs first) | Up to 24 months after last patient randomized |
| Treatment free survival |
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Inclusion Criteria:
Age ≥18 years to ≤ 75 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Patients with platinum-sensitive, secondary relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Front-line or second-line treatment may have included maintenance therapy (i.e. bevacizumab, PARP inhibitor)
Secondary cytoreductive surgery (SCR) when first recurrence
Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. Single or localized lesions identified by CT, or MRI, or positron emission tomography/computed tomography (PET/CT). PI and Co-PI reach consensus if extensive lesions or carcinomatosis.
It can be included if single lesion outside the peritoneal cavity can be resected.
No more than 3 disease lesions by central-reviewed PET/CT imaging if the participated center has never participated in any surgical trials on ovarian cancer before.
Patients who have given their signed and written informed consent and their consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Jiang, M.D. | Contact | +862164041990 | jiang.rong@zs-hospital.sh.cn | |
| Yuting Luan, R.N. | Contact | +862164041990 | yutingluan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tingyan Shi, M.D., Ph.D. | Shanghai Gynecologic Oncology Group | Principal Investigator |
| Rongyu Zang, M.D., Ph.D. | Shanghai Gynecologic Oncology Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32319233 | Derived | Shi T, Yin S, Zhu J, Zhang P, Liu J, Zhu Y, Wu S, Chen X, Wang X, Teng Y, Zhu T, Yu A, Zhang Y, Feng Y, Huang H, Bao W, Li Y, Jiang W, Zhang P, Li J, Ai Z, Zhang W, Jia H, Zhang Y, Jiang R, Zhang J, Gao W, Luan Y, Zang R. A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study. J Gynecol Oncol. 2020 May;31(3):e61. doi: 10.3802/jgo.2020.31.e61. |
| Label | URL |
|---|---|
| Shanghai Gynecologic Oncology Group | View source |
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| OTHER |
randomized umbrella clinical trial
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| carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... | Drug | Salvage chemotherapy |
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| Niraparib | Drug | Niraparib maintenance therapy |
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It is the area between Kaplan-Meier curves for two time-to-event end points: 1) time to protocol chemotherapy cessation and 2) time to first subsequent anticancer therapy initiation or death, whichever occurred first.
| Up to 24 months after last patient randomized |
| Overall survival | from date of randomization until the date of death from any cause | Approximately up to 24 months after last patient randomized |
| 30-day post-operative complications | surgical complications grading criteria will be adopted for evaluating the perioperative complications | From the operation until after 30 days |
| Quality of life assessment | the European Organization for Research and Treatment (EORTC) core quality of life questionnaire (QLQ-C30, version 3.0) The total score (range from 0 to 1,000) | baseline; 6 and 12 months after randomization |
| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangzhou | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | China |
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| Fudan University | Not yet recruiting | Shanghai | China |
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| Shanghai Jiao Tong University | Not yet recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D005185 | Fallopian Tube 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 |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D016190 | Carboplatin |
| C080625 | taxane |
| C545685 | niraparib |
| D008283 | Maintenance |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005159 | Health Care Facilities Workforce and Services |
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