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

Primary Purpose

Ovarian Cancer Recurrent, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Surgery
carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Niraparib
Sponsored by
Shanghai Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer Recurrent focused on measuring reurrent Ovarian Cancer, Secondary Cytoreductive Surgery, Chemotherapy, Niraparib maintenance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University Shanghai Zhongshan HospitalRecruiting
  • Sun Yat-sen University Cancer Center
  • Zhejiang Cancer Hospital
  • Fudan University
  • Shanghai Jiao Tong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surgery

No surgery

Arm Description

Intervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib

Intervention: Drug: Platinum-based chemotherapy and Niraparib

Outcomes

Primary Outcome Measures

12-month disease non-progression rate
12-month non-progression rate

Secondary Outcome Measures

Progression-free survival
from date of randomization until the date of 3rd relapse/progression or death (whatever occurs first)
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.
Overall survival
from date of randomization until the date of death from any cause
30-day post-operative complications
surgical complications grading criteria will be adopted for evaluating the perioperative complications
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)

Full Information

First Posted
June 5, 2019
Last Updated
March 4, 2022
Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Fudan University, Shanghai Jiao Tong University School of Medicine, Zhejiang Cancer Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03983226
Brief Title
Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
Official Title
A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Fudan University, Shanghai Jiao Tong University School of Medicine, Zhejiang Cancer Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer Recurrent, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Keywords
reurrent Ovarian Cancer, Secondary Cytoreductive Surgery, Chemotherapy, Niraparib maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized umbrella clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Experimental
Arm Description
Intervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
Arm Title
No surgery
Arm Type
Active Comparator
Arm Description
Intervention: Drug: Platinum-based chemotherapy and Niraparib
Intervention Type
Procedure
Intervention Name(s)
Surgery
Other Intervention Name(s)
secondary cytoreduction
Intervention Description
Tumor debulking surgery (surgery in recurrent ovarian disease)
Intervention Type
Drug
Intervention Name(s)
carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Other Intervention Name(s)
third-line therapy
Intervention Description
Salvage chemotherapy
Intervention Type
Drug
Intervention Name(s)
Niraparib
Other Intervention Name(s)
maintenance therapy
Intervention Description
Niraparib maintenance therapy
Primary Outcome Measure Information:
Title
12-month disease non-progression rate
Description
12-month non-progression rate
Time Frame
up to 12 months after last patient randomized
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
from date of randomization until the date of 3rd relapse/progression or death (whatever occurs first)
Time Frame
Up to 24 months after last patient randomized
Title
Treatment free survival
Description
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.
Time Frame
Up to 24 months after last patient randomized
Title
Overall survival
Description
from date of randomization until the date of death from any cause
Time Frame
Approximately up to 24 months after last patient randomized
Title
30-day post-operative complications
Description
surgical complications grading criteria will be adopted for evaluating the perioperative complications
Time Frame
From the operation until after 30 days
Title
Quality of life assessment
Description
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)
Time Frame
baseline; 6 and 12 months after randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Jiang, M.D.
Phone
+862164041990
Email
jiang.rong@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuting Luan, R.N.
Phone
+862164041990
Email
yutingluan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tingyan Shi, M.D., Ph.D.
Organizational Affiliation
Shanghai Gynecologic Oncology Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rongyu Zang, M.D., Ph.D.
Organizational Affiliation
Shanghai Gynecologic Oncology Group
Official's Role
Study Chair
Facility Information:
Facility Name
Fudan University Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Jiang, MD
Phone
+862164041990
Email
jiang.rong@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Yuting Luan, RN
Phone
+862164041990
Email
yutingluan@163.com
First Name & Middle Initial & Last Name & Degree
Rongyu Zang, MD,PhD
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanling Feng
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Gao
Facility Name
Fudan University
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Jiang
Facility Name
Shanghai Jiao Tong University
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Bao

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32319233
Citation
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.
Results Reference
derived
Links:
URL
http://www.ShanghaiGOG.org
Description
Shanghai Gynecologic Oncology Group

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

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