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Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Primary debulking surgery
Neoadjuvant chemotherapy
PARP inhibitor
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 focused on measuring Ovarian Cancer, Primary Debulking Surgery, Neoadjuvant chemotherapy, Poly-adenosine Ribose Phosphate Inhbitors (PARPi)

Eligibility Criteria

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

Inclusion Criteria:

  • Females aged ≥ 18 years.
  • Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
  • Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative PET/CT examination
  • Complete cytoreduction can be achieved based on PET/CT examination
  • Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing
  • Performance status (ECOG 0-2)
  • Good ASA score (1/2)

  • Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:

    1. white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
    2. serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
    3. serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
  • Comply with the study protocol and follow-up.
  • Patients who have given their written informed consent.

Exclusion Criteria:

  • Non-epithelial ovarian malignancies and borderline tumors
  • Low grade ovarian cancer
  • Mucinous ovarian cancer
  • Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases
  • Patient has a known hypersensitivity to the components of niraparib or its excipients
  • Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).
  • Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
  • Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.

Sites / Locations

  • Zhongshan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Upfront cytoreductive surgery with maintenance therapy

Neoadjuvant chemotherapy with maintenance therapy

Arm Description

Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy.

Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy.

Outcomes

Primary Outcome Measures

3-year overall survival
The proportion of patients alive at 3 years after entry into the study

Secondary Outcome Measures

Overall survival
Time from entry into the study to any cause of death
Progression-free survival
Time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first
Post-operative complications
The surgical complications will be evaluated at 30-day, 60-day, 90-day after upfront cytoreductive surgery or interval debulking surgery
Quality of life assessments
QLQ-C30, FACT-Q (baseline; 6 months, 12 months, 24 months and 36 months after randomization)
Accumulated treatment-free survival
Time from the date of randomization to death from any reason, minus the total treatment time of surgery and chemotherapy after randomization (regardless of targeted therapy)
TFST
Time from the date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first
TSST
Time from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurred first
The pattern of the first relapse
The number and sites of the first relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups.

Full Information

First Posted
January 17, 2022
Last Updated
January 17, 2022
Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05200260
Brief Title
Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
Official Title
A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Fudan 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
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
Detailed Description
The purpose of this trial is to answer the fundamental question 'The Optimal Timing of Surgery' combined with Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Keywords
Ovarian Cancer, Primary Debulking Surgery, Neoadjuvant chemotherapy, Poly-adenosine Ribose Phosphate Inhbitors (PARPi)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Upfront cytoreductive surgery with maintenance therapy
Arm Type
Experimental
Arm Description
Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy.
Arm Title
Neoadjuvant chemotherapy with maintenance therapy
Arm Type
Active Comparator
Arm Description
Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy.
Intervention Type
Procedure
Intervention Name(s)
Primary debulking surgery
Other Intervention Name(s)
PDS
Intervention Description
Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5.
Intervention Type
Procedure
Intervention Name(s)
Neoadjuvant chemotherapy
Other Intervention Name(s)
Neoadjuvant chemotherapy followed by interval debulking surgery, NACT-IDS
Intervention Description
3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.
Intervention Type
Drug
Intervention Name(s)
PARP inhibitor
Other Intervention Name(s)
Niraparib
Intervention Description
For patients with CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors. In this trial, Niraparib 200mg po qd is suggested after the front-line therapy.
Primary Outcome Measure Information:
Title
3-year overall survival
Description
The proportion of patients alive at 3 years after entry into the study
Time Frame
Participants will be followed for at least 3 years after randomization
Secondary Outcome Measure Information:
Title
Overall survival
Description
Time from entry into the study to any cause of death
Time Frame
Participants will be followed for at least 3 years after randomization
Title
Progression-free survival
Description
Time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first
Time Frame
Participants will be followed for at least 3 years after randomization
Title
Post-operative complications
Description
The surgical complications will be evaluated at 30-day, 60-day, 90-day after upfront cytoreductive surgery or interval debulking surgery
Time Frame
Participants will be followed up to 3 months after randomization
Title
Quality of life assessments
Description
QLQ-C30, FACT-Q (baseline; 6 months, 12 months, 24 months and 36 months after randomization)
Time Frame
Participants will be followed for at least 3 years after randomization
Title
Accumulated treatment-free survival
Description
Time from the date of randomization to death from any reason, minus the total treatment time of surgery and chemotherapy after randomization (regardless of targeted therapy)
Time Frame
Participants will be followed for at least 3 years or death after randomization
Title
TFST
Description
Time from the date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first
Time Frame
Participants will be followed for at least 3 years or death after randomization
Title
TSST
Description
Time from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurred first
Time Frame
Participants will be followed for at least 3 years or death after randomization
Title
The pattern of the first relapse
Description
The number and sites of the first relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups.
Time Frame
Participants will be followed for at least 3 years or death after randomization

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females aged ≥ 18 years. Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative PET/CT examination Complete cytoreduction can be achieved based on PET/CT examination Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing Performance status (ECOG 0-2) Good ASA score (1/2) Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery: white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL, serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement, serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL. Comply with the study protocol and follow-up. Patients who have given their written informed consent. Exclusion Criteria: Non-epithelial ovarian malignancies and borderline tumors Low grade ovarian cancer Mucinous ovarian cancer Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases Patient has a known hypersensitivity to the components of niraparib or its excipients Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity). Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Libing Xiang
Phone
86 21 64041990
Ext
2801
Email
xiang.libing@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Jiang
Phone
86 21 64041990
Ext
2801
Email
jiang.rong@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Libing Xiang
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

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