Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03983226
Other study ID # SGOG OV5
Secondary ID SGOG OV-05
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 18, 2019
Est. completion date December 2026

Study information

Verified date March 2022
Source Shanghai Gynecologic Oncology Group
Contact Rong Jiang, M.D.
Phone +862164041990
Email jiang.rong@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 167
Est. completion date December 2026
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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) - 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 with borderline tumors as well as non-epithelial tumors. - 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.

Study Design


Intervention

Procedure:
Surgery
Tumor debulking surgery (surgery in recurrent ovarian disease)
Drug:
carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Salvage chemotherapy
Niraparib
Niraparib maintenance therapy

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou
China Zhejiang Cancer Hospital Hangzhou
China Fudan University Shanghai
China Fudan University Shanghai Zhongshan Hospital Shanghai Shanghai
China Shanghai Jiao Tong University Shanghai

Sponsors (5)

Lead Sponsor Collaborator
Shanghai Gynecologic Oncology Group Fudan University, Shanghai Jiao Tong University School of Medicine, Sun Yat-sen University, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 12-month disease non-progression rate 12-month non-progression rate up to 12 months after last patient randomized
Secondary 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
Secondary Treatment free survival 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
Secondary Overall survival from date of randomization until the date of death from any cause Approximately up to 24 months after last patient randomized
Secondary 30-day post-operative complications surgical complications grading criteria will be adopted for evaluating the perioperative complications From the operation until after 30 days
Secondary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03393884 - Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2) Phase 1/Phase 2
Completed NCT04546373 - Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
Active, not recruiting NCT05456685 - IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer Phase 2
Completed NCT01442051 - Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer N/A
Completed NCT02928549 - Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study
Active, not recruiting NCT03648489 - Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma) Phase 2
Not yet recruiting NCT04983550 - Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC Phase 2
Completed NCT02480374 - Study of Safety & Biological Activity of IP IMNN-001 (Also Known as GEN-1) With Neoadjuvant Chemo in Ovarian Cancer Phase 1
Completed NCT01899599 - PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer Phase 2
Completed NCT03480750 - Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer Phase 1/Phase 2
Completed NCT01610206 - A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer Phase 2
Completed NCT01031381 - Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer Phase 2
Completed NCT01219777 - Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian Phase 1
Completed NCT00959582 - Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143) Phase 1
Completed NCT00801320 - Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer N/A
Completed NCT00768144 - Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma Phase 2
Suspended NCT00753480 - A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Phase 1
Completed NCT00702299 - Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer Phase 1
Recruiting NCT02349958 - Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy Phase 2
Completed NCT00390234 - Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma Phase 2