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出境医 / 临床实验 / Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

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

Study Description
Brief Summary:
The purpose of this study is to evaluate the role of cytoreductive surgery and Niraparib maintenance in platinum-sensitive secondary recurrent ovarian cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Recurrent Fallopian Tube Cancer Primary Peritoneal Carcinoma Procedure: Surgery Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... Drug: Niraparib Phase 2

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 who never received secondary cytoreduction when recurrent.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2024
Arms and Interventions
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 Name: secondary cytoreduction

Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Salvage chemotherapy
Other Name: third-line therapy

Drug: Niraparib
Niraparib maintenance therapy
Other Name: 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 Name: third-line therapy

Drug: Niraparib
Niraparib maintenance therapy
Other Name: maintenance therapy

Outcome Measures
Primary Outcome Measures :
  1. 12-month disease non-progression rate [ Time Frame: up to 12 months after last patient randomized ]
    12-month non-progression rate


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Up to 24 months after last patient randomized ]
    from date of randomization until the date of 3rd relapse/progression or death (whatever occurs first)

  2. Treatment free intervals [ Time Frame: Up to 24 months after last patient randomized ]
    the intervals of the ending date from system anticancer therapy to the starting date of the subsequent anticancer therapy or death

  3. Overall Survival [ Time Frame: Approximately up to 24 months after last patient randomized ]
    from date of randomization until the date of death from any cause

  4. 30-day post-operative complications [ Time Frame: From the operation until after 30 days ]
    surgical complications grading criteria will be adopted for evaluating the perioperative complications

  5. Quality of life assessment [ Time Frame: 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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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, which is defined as those with platinum-free interval of 6 months or more.
  • Front-line or second-line treatment may have included maintenance therapy
  • Never received secondary cytoreductive surgery when recurrence
  • 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-look surgery, or palliative surgery planned.
  • Patients whom have already undergone secondary cytoreduction for recurrent disease are excluded.
  • 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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Rong Jiang, M.D. +862164041990 jiang.rong@zs-hospital.sh.cn
Contact: Yuting Luan, R.N. +862164041990 yutingluan@163.com

Locations
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China, Shanghai
Fudan University Shanghai Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Rong Jiang, MD    +862164041990    jiang.rong@zs-hospital.sh.cn   
Contact: Yuting Luan, RN    +862164041990    yutingluan@163.com   
Principal Investigator: Rongyu Zang, MD,PhD         
China
Sun Yat-sen University Cancer Center Not yet recruiting
Guangzhou, China
Contact: Yanling Feng         
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, China
Contact: Wen Gao         
Fudan University Not yet recruiting
Shanghai, China
Contact: Wei Jiang         
Shanghai Jiao Tong University Not yet recruiting
Shanghai, China
Contact: Wei Bao         
Sponsors and Collaborators
Shanghai Gynecologic Oncology Group
Fudan University
Shanghai Jiao Tong University School of Medicine
Zhejiang Cancer Hospital
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Tingyan Shi, M.D., Ph.D. Shanghai Gynecologic Oncology Group
Study Chair: Rongyu Zang, M.D., Ph.D. Shanghai Gynecologic Oncology Group
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date March 5, 2020
Actual Study Start Date  ICMJE October 18, 2019
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2019)
12-month disease non-progression rate [ Time Frame: up to 12 months after last patient randomized ]
12-month non-progression rate
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
6-month disease non-progression rate [ Time Frame: 6 months ]
6-month non-progression rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Progression-free survival [ Time Frame: 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 intervals [ Time Frame: Up to 24 months after last patient randomized ]
    the intervals of the ending date from system anticancer therapy to the starting date of the subsequent anticancer therapy or death
  • Overall Survival [ Time Frame: Approximately up to 24 months after last patient randomized ]
    from date of randomization until the date of death from any cause
  • 30-day post-operative complications [ Time Frame: From the operation until after 30 days ]
    surgical complications grading criteria will be adopted for evaluating the perioperative complications
  • Quality of life assessment [ Time Frame: 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Progression-free survival [ Time Frame: 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 intervals [ Time Frame: Up to 24 months after last patient randomized ]
    the intervals of the ending date from system anticancer therapy to the starting date of the subsequent anticancer therapy or death
  • Overall Survival [ Time Frame: Approximately up to 24 months after last patient randomized ]
    from date of randomization until the date of death from any cause
  • 30-day post-operative complications [ Time Frame: From the operation until after 30 days ]
    surgical complications grading criteria will be adopted for evaluating the perioperative complications
  • Quality of life assessment [ Time Frame: baseline; 6 and 12 months after randomization ]
    the European Organization for Research and Treatment (EORTC) quality of life questionnaires
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
Official Title  ICMJE A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer
Brief Summary The purpose of this study is to evaluate the role of cytoreductive surgery and Niraparib maintenance in platinum-sensitive secondary recurrent ovarian cancer.
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 who never received secondary cytoreduction when recurrent.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer Recurrent
  • Fallopian Tube Cancer
  • Primary Peritoneal Carcinoma
Intervention  ICMJE
  • Procedure: Surgery
    Tumor debulking surgery (surgery in recurrent ovarian disease)
    Other Name: secondary cytoreduction
  • Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
    Salvage chemotherapy
    Other Name: third-line therapy
  • Drug: Niraparib
    Niraparib maintenance therapy
    Other Name: maintenance therapy
Study Arms  ICMJE
  • Experimental: Surgery

    Intervention:

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

    Interventions:
    • Procedure: Surgery
    • Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
    • Drug: Niraparib
  • Active Comparator: No surgery
    Intervention: Drug: Platinum-based chemotherapy and Niraparib
    Interventions:
    • Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
    • Drug: Niraparib
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2020)
96
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2019)
76
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, which is defined as those with platinum-free interval of 6 months or more.
  • Front-line or second-line treatment may have included maintenance therapy
  • Never received secondary cytoreductive surgery when recurrence
  • 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-look surgery, or palliative surgery planned.
  • Patients whom have already undergone secondary cytoreduction for recurrent disease are excluded.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rong Jiang, M.D. +862164041990 jiang.rong@zs-hospital.sh.cn
Contact: Yuting Luan, R.N. +862164041990 yutingluan@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983226
Other Study ID Numbers  ICMJE SGOG OV5
SGOG OV-05 ( Other Identifier: Shanghai Gynecologic Oncology Group )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shanghai Gynecologic Oncology Group
Study Sponsor  ICMJE Shanghai Gynecologic Oncology Group
Collaborators  ICMJE
  • Fudan University
  • Shanghai Jiao Tong University School of Medicine
  • Zhejiang Cancer Hospital
  • Sun Yat-sen University
Investigators  ICMJE
Principal Investigator: Tingyan Shi, M.D., Ph.D. Shanghai Gynecologic Oncology Group
Study Chair: Rongyu Zang, M.D., Ph.D. Shanghai Gynecologic Oncology Group
PRS Account Shanghai Gynecologic Oncology Group
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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