Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer Recurrent Fallopian Tube Cancer Primary Peritoneal Carcinoma | Procedure: Surgery Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... Drug: Niraparib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 96 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | randomized clinical trial |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer |
Actual Study Start Date : | October 18, 2019 |
Estimated Primary Completion Date : | June 2023 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Surgery
Intervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib |
Procedure: Surgery
Tumor debulking surgery (surgery in recurrent ovarian disease)
Other Name: secondary cytoreduction
Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... Salvage chemotherapy
Other Name: third-line therapy
Drug: Niraparib Niraparib maintenance therapy
Other Name: maintenance therapy
|
Active Comparator: No surgery
Intervention: Drug: Platinum-based chemotherapy and Niraparib
|
Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Salvage chemotherapy
Other Name: third-line therapy
Drug: Niraparib Niraparib maintenance therapy
Other Name: maintenance therapy
|
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rong Jiang, M.D. | +862164041990 | jiang.rong@zs-hospital.sh.cn | |
Contact: Yuting Luan, R.N. | +862164041990 | yutingluan@163.com |
China, Shanghai | |
Fudan University Shanghai Zhongshan Hospital | Recruiting |
Shanghai, Shanghai, China, 200032 | |
Contact: Rong Jiang, MD +862164041990 jiang.rong@zs-hospital.sh.cn | |
Contact: Yuting Luan, RN +862164041990 yutingluan@163.com | |
Principal Investigator: Rongyu Zang, MD,PhD | |
China | |
Sun Yat-sen University Cancer Center | Not yet recruiting |
Guangzhou, China | |
Contact: Yanling Feng | |
Zhejiang Cancer Hospital | Not yet recruiting |
Hangzhou, China | |
Contact: Wen Gao | |
Fudan University | Not yet recruiting |
Shanghai, China | |
Contact: Wei Jiang | |
Shanghai Jiao Tong University | Not yet recruiting |
Shanghai, China | |
Contact: Wei Bao |
Principal Investigator: | Tingyan Shi, M.D., Ph.D. | Shanghai Gynecologic Oncology Group | |
Study Chair: | Rongyu Zang, M.D., Ph.D. | Shanghai Gynecologic Oncology Group |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | June 5, 2019 | ||||||||
First Posted Date ICMJE | June 12, 2019 | ||||||||
Last Update Posted Date | March 5, 2020 | ||||||||
Actual Study Start Date ICMJE | October 18, 2019 | ||||||||
Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
12-month disease non-progression rate [ Time Frame: up to 12 months after last patient randomized ] 12-month non-progression rate
|
||||||||
Original Primary Outcome Measures ICMJE |
6-month disease non-progression rate [ Time Frame: 6 months ] 6-month non-progression rate
|
||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE |
|
||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial) | ||||||||
Official Title ICMJE | A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer | ||||||||
Brief Summary | The purpose of this study is to evaluate the role of cytoreductive surgery and Niraparib maintenance in platinum-sensitive secondary recurrent ovarian cancer. | ||||||||
Detailed Description | 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 who never received secondary cytoreduction when recurrent. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: randomized clinical trial Masking: None (Open Label)Primary Purpose: Treatment |
||||||||
Condition ICMJE |
|
||||||||
Intervention ICMJE |
|
||||||||
Study Arms ICMJE |
|
||||||||
Publications * | 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. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
96 | ||||||||
Original Estimated Enrollment ICMJE |
76 | ||||||||
Estimated Study Completion Date ICMJE | December 2024 | ||||||||
Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03983226 | ||||||||
Other Study ID Numbers ICMJE | SGOG OV5 SGOG OV-05 ( Other Identifier: Shanghai Gynecologic Oncology Group ) |
||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE |
|
||||||||
Responsible Party | Shanghai Gynecologic Oncology Group | ||||||||
Study Sponsor ICMJE | Shanghai Gynecologic Oncology Group | ||||||||
Collaborators ICMJE |
|
||||||||
Investigators ICMJE |
|
||||||||
PRS Account | Shanghai Gynecologic Oncology Group | ||||||||
Verification Date | March 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |