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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 167
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rong Jiang, M.D.; Phone Number: +862164041990; Email: jiang.rong@zs-hospital.sh.cn
• Study Contact Backup: Name: Yuting Luan, R.N.; Phone Number: +862164041990; Email: yutingluan@163.com

Study Locations

• China
  • Guangzhou, China
    • Not yet recruiting
    • Sun Yat-sen University Cancer Center
  • Hangzhou, China
    • Not yet recruiting
    • Zhejiang Cancer Hospital
    • Contact: Wen Gao
  • Shanghai, China
    • Not yet recruiting
    • Fudan University
    • Contact: Wei Jiang
  • Shanghai, China
    • Not yet recruiting
    • Shanghai Jiao Tong University
    • Contact: Wei Bao
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Zhongshan Hospital
      • Contact: Rong Jiang, MD; Phone Number: +862164041990; Email: jiang.rong@zs-hospital.sh.cn
      • Contact: Yuting Luan, RN; Phone Number: +862164041990; Email: yutingluan@163.com
      • Principal Investigator: Rongyu Zang, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery; Intervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib	Procedure: Surgery; Tumor debulking surgery (surgery in recurrent ovarian disease); Other Names: secondary cytoreduction; Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...; Salvage chemotherapy; Other Names: third-line therapy; Drug: Niraparib; Niraparib maintenance therapy; Other Names: maintenance therapy
Active Comparator: No surgery; Intervention: Drug: Platinum-based chemotherapy and Niraparib	Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...; Salvage chemotherapy; Other Names: third-line therapy; Drug: Niraparib; Niraparib maintenance therapy; Other Names: maintenance therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-month disease non-progression rate	12-month non-progression rate	up to 12 months after last patient randomized

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Overall survival	from date of randomization until the date of death from any cause	Approximately up to 24 months after last patient randomized
30-day post-operative complications	surgical complications grading criteria will be adopted for evaluating the perioperative complications	From the operation until after 30 days
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

Collaborators and Investigators

• Sponsor: Shanghai Gynecologic Oncology Group
• Collaborators: Zhejiang Cancer Hospital; Sun Yat-sen University; Fudan University; Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Tingyan Shi, M.D., Ph.D., Shanghai Gynecologic Oncology Group; Study Chair: Rongyu Zang, M.D., Ph.D., Shanghai Gynecologic Oncology Group

Publications and helpful links

General Publications

• 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. Erratum In: J Gynecol Oncol. 2022 Jul;33(4):e63.

Helpful Links

• Shanghai Gynecologic Oncology Group

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Chemotherapy; Secondary Cytoreductive Surgery; reurrent Ovarian Cancer; Niraparib maintenance
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Disease Attributes; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Recurrence; Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Poly(ADP-ribose) Polymerase Inhibitors; Antibiotics, Antineoplastic; Gemcitabine; Carboplatin; Doxorubicin; Niraparib; Taxane
• Other Study ID Numbers: SGOG OV5; SGOG OV-05 (Other Identifier: Shanghai Gynecologic Oncology Group)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No