Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
NCT ID: NCT03983226
Last Updated: 2022-03-18
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
167 participants
INTERVENTIONAL
2019-10-18
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?
NCT01611766
Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial
NCT05607329
A Phase II Trial to Explore Niraparib and Anlotinib Maintenance Retreatment in Platinum-Sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi
NCT05385068
A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)
NCT06824467
Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer
NCT04507841
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Surgery
Intervention:
Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
Surgery
Tumor debulking surgery (surgery in recurrent ovarian disease)
carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Salvage chemotherapy
Niraparib
Niraparib maintenance therapy
No surgery
Intervention: Drug: Platinum-based chemotherapy and Niraparib
carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Salvage chemotherapy
Niraparib
Niraparib maintenance therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surgery
Tumor debulking surgery (surgery in recurrent ovarian disease)
carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Salvage chemotherapy
Niraparib
Niraparib maintenance therapy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
* Cohort 1 and Cohort 3: No prior use of PARP inhibitor.
* Cohort 2: Prior use of PARP inhibitor.
* Cohort 3: No prior use of PARP inhibitor.
* Secondary cytoreductive surgery (SCR) when first recurrence
* Cohort 1 and Cohort 2: Never received SCR
* Cohort 2: Never received SCR
* Cohort 3: Received SCR
* 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
* Patients for interval-debulking, or for second- or third-look surgery, or palliative surgery planned.
* Impossible to assess the resectability. Radiological signs suggesting complete resection is impossible.
* Patients who have received more than two previous regimen of chemotherapy (maintenance is not considered a third regimen).
* Third relapse or more.
* Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
* Progression during chemotherapy or recurrence within 6 months after second-line platinum-based therapy
* Any contradiction not allowing surgery and/or chemotherapy and/or or Niraparib
* Accompanied by hypoxia serious chronic obstructive pulmonary disease
* Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine.
* Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency
* Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy.
* Uncontrolled diabetes
* Uncontrolled epilepsy need long-term antiepileptic treatment.
* Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents.
* ≥3 grade anemia, neutropenia or thrombocytopenia due to chemotherapy, and lasted for more than 4 weeks
* Patients with a known hypersensitivity to Niraparib or any of the excipients of the product.
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fudan University
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Zhejiang Cancer Hospital
OTHER
Sun Yat-sen University
OTHER
Shanghai Gynecologic Oncology Group
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tingyan Shi, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Gynecologic Oncology Group
Rongyu Zang, M.D., Ph.D.
Role: STUDY_CHAIR
Shanghai Gynecologic Oncology Group
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fudan University Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Fudan University
Shanghai, , China
Shanghai Jiao Tong University
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yanling Feng
Role: primary
Wen Gao
Role: primary
Wei Jiang
Role: primary
Wei Bao
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Shanghai Gynecologic Oncology Group
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SGOG OV-05
Identifier Type: OTHER
Identifier Source: secondary_id
SGOG OV5
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.