Evidence map›Paper›PMID 32319233›Full record

Trial reportJournal of gynecologic oncology2020

A phase II trial of cytoreductive surgery combined with niraparib maintenance in platinum-sensitive, secondary recurrent ovarian cancer: SGOG SOC-3 study.

Tingyan Shi, Sheng Yin, Jianqing Zhu, Ping Zhang, Jihong Liu, Yaping Zhu, Sufang Wu, Xiaojun Chen, Xipeng Wang, Yincheng Teng and 19 more

Erratum issued Registry-linked trialOpen access · diamondAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of gynecologic oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03983226 (A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03983226 phase2recruitingnot on this map

A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer

TypeinterventionalSponsorShanghai Gynecologic Oncology GroupRan2019 to 2026Enrolled167ConditionsOvarian Cancer Recurrent, Fallopian Tube Cancer, Primary Peritoneal CarcinomaArmsSurgery, carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin..., Niraparib
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Predicting Complete Cytoreduction with Preoperative [Diagnostics (Basel, Switzerland) · 2024
    Review
  3. Review
  4. Article
  5. Review
  6. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 7 institutions in 1 country.

Tingyan ShiOvarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China. tyshi80@163.com.ORCID 0000-0002-5356-0365
Sheng YinOvarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID 0000-0001-6244-3462
Jianqing ZhuDepartment of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.ORCID 0000-0001-5736-7397
Ping ZhangDepartment of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.ORCID 0000-0003-1995-9775
Jihong LiuDepartment of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.ORCID 0000-0001-9711-2428
Yaping ZhuDepartment of Obstetrics and Gynecology, Shanghai General Hospital, Shanghai, China.ORCID 0000-0003-3163-3815
Sufang WuDepartment of Obstetrics and Gynecology, Shanghai General Hospital, Shanghai, China.ORCID 0000-0003-1216-4814
Xiaojun ChenDepartment of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.ORCID 0000-0002-5493-1500
Xipeng WangDepartment of Gynecology and Obstetrics, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0002-7555-4185
Yincheng TengDepartment of Gynecology and Obstetrics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.ORCID 0000-0002-6451-4479
Tao ZhuDepartment of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.ORCID 0000-0002-2921-4067
Aijun YuDepartment of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.ORCID 0000-0003-0142-7658
Yingli ZhangDepartment of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.ORCID 0000-0001-6929-8480
Yanling FengDepartment of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.ORCID 0000-0002-3485-1490
He HuangDepartment of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.ORCID 0000-0002-6223-4799
Wei BaoDepartment of Obstetrics and Gynecology, Shanghai General Hospital, Shanghai, China.ORCID 0000-0002-3942-7218
Yanli LiDepartment of Obstetrics and Gynecology, Shanghai General Hospital, Shanghai, China.ORCID 0000-0003-0133-2261
Wei JiangDepartment of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.ORCID 0000-0002-9998-0066
Ping ZhangDepartment of Gynecology and Obstetrics, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0003-1428-692X
Jiarui LiDepartment of Gynecology and Obstetrics, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0003-2246-1302
Zhihong AiDepartment of Gynecology and Obstetrics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.ORCID 0000-0002-8220-8192
Wei ZhangDepartment of Biostatistics, Fudan University, Shanghai, China.ORCID 0000-0002-9601-4823
Huixun JiaClinical Statistics Center, Shanghai General Hospital, Shanghai, China.ORCID 0000-0001-9341-5587
Yuqin ZhangOvarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID 0000-0003-0078-8574
Rong JiangOvarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID 0000-0002-2138-167X
Jiejie ZhangDepartment of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.ORCID 0000-0001-8114-1988
Wen GaoDepartment of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.ORCID 0000-0002-7404-5485
Yuting LuanOvarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID 0000-0003-4494-6167
Rongyu ZangOvarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID 0000-0002-1334-2398
Fudan University · CNShanghai Jiao Tong University · CNZhejiang Cancer Hospital · CNShanghai First People's Hospital · CNSun Yat-sen University · CNObstetrics and Gynecology Hospital of Fudan University · CNShanghai Clinical Research Center · CN

Funding

Clinical Trial Project of Zhongshan Hospital, Fudan University 2018ZSLC33
6 · The paper itself

Abstract

backgroundIn China, secondary cytoreductive surgery (SCR) has been widely used in ovarian cancer (OC) over the past two decades. Although Gynecologic Oncology Group-0213 trial did not show its overall survival benefit in first relapsed patients, the questions on patient selection and effect of subsequent targeting therapy are still open. The preliminary data from our pre-SOC1 phase II study showed that selected patients with second relapse who never received SCR at recurrence may still benefit from surgery. Moreover, poly(ADP-ribose) polymerase inhibitors (PARPi) maintenance now has been a standard care for platinum sensitive relapsed OC. To our knowledge, no published or ongoing trial is trying to answer the question if patient can benefit from a potentially complete resection combined with PARPi maintenance in OC patients with secondary recurrence.

methodsSOC-3 is a multi-center, open, randomized, controlled, phase II trial of SCR followed by chemotherapy and niraparib maintenance vs chemotherapy and niraparib maintenance in patients with platinum-sensitive second relapsed OC who never received SCR at recurrence. To guarantee surgical quality, if the sites had no experience of participating in any OC-related surgical trials, the number of recurrent lesions evaluated by central-reviewed positron emission tomography-computed tomography image shouldn't be more than 3. Eligible patients are randomly assigned in a 1:1 ratio to receive either SCR followed by 6 cycles of platinum-based chemotherapy and niraparib maintenance or 6 cycles of platinum-based chemotherapy and niraparib maintenance alone. Patients who undergo at least 4 cycles of chemotherapy and must be, in the opinion of the investigator, without disease progression, will be assigned niraparib maintenance. Major inclusion criteria are secondary relapsed OC with a platinum-free interval of no less than 6 months and a possibly complete resection. Major exclusion criteria are borderline tumors and non-epithelial ovarian malignancies, received debulking surgery at recurrence and impossible to complete resection. The sample size is 96 patients. Primary endpoint is 12-month non-progression rate.

trial registrationClinicalTrials.gov Identifier: NCT03983226.

Indexed as

Cytoreduction Surgical ProceduresOvarian NeoplasmsAdolescentChinaFemaleHumansIndazolesNeoplasm Recurrence, LocalPiperidinesPositron Emission Tomography Computed TomographyQuality of LifeIndazolesniraparibPiperidinesChemotherapyClinical TrialCytoreductive SurgeryOvarian NeoplasmsPoly(ADP-ribose) Polymerase Inhibitors

Identifiers

PMID32319233
PMCPMC7189080
OpenAlexW3017170799

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.