Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

Fallopian Tube Cancer Clinical Trial

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer Recurrent
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

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

External Links

•   Shanghai Gynecologic Oncology Group