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

Phase 2

Recruiting

• Conditions: Ovarian Cancer Recurrent; Primary Peritoneal Carcinoma; Fallopian Tube Cancer
• Interventions: Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...; Procedure: Surgery; Drug: Niraparib

• Registration Number: NCT03983226
• Lead Sponsor: Shanghai Gynecologic Oncology Group

Brief 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.

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.

Study Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-12
• Study Start: 2019-10-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-18
• Primary Completion: 2025-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 167

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No surgery	carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...	Intervention: Drug: Platinum-based chemotherapy and Niraparib
Surgery	Surgery	Intervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
Surgery	carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...	Intervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
Surgery	Niraparib	Intervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
No surgery	Niraparib	Intervention: Drug: Platinum-based chemotherapy and Niraparib

Primary Outcome Measures

Name	Time	Method
12-month disease non-progression rate	up to 12 months after last patient randomized	12-month non-progression rate

Secondary Outcome Measures

Name	Time	Method
30-day post-operative complications	From the operation until after 30 days	surgical complications grading criteria will be adopted for evaluating the perioperative complications
Overall survival	Approximately up to 24 months after last patient randomized	from date of randomization until the date of death from any cause
Quality of life assessment	baseline; 6 and 12 months after randomization	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)
Progression-free survival	Up to 24 months after last patient randomized	from date of randomization until the date of 3rd relapse/progression or death (whatever occurs first)
Treatment free survival	Up to 24 months after last patient randomized	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.

Trial Locations

Locations (5)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, China

Fudan University Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Fudan University; 🇨🇳 Shanghai, China

Shanghai Jiao Tong University; 🇨🇳 Shanghai, China