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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05200260
Other study ID # SAT-1
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date February 2022
Est. completion date February 2027

Study information

Verified date January 2022
Source Shanghai Gynecologic Oncology Group
Contact Libing Xiang
Phone 86 21 64041990
Email xiang.libing@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 207
Est. completion date February 2027
Est. primary completion date February 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Procedure:
Primary debulking surgery
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.
Neoadjuvant chemotherapy
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.
Drug:
PARP inhibitor
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.

Locations

Country Name City State
China Zhongshan Hospital, Fudan University Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Gynecologic Oncology Group Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 3-year overall survival The proportion of patients alive at 3 years after entry into the study Participants will be followed for at least 3 years after randomization
Secondary Overall survival Time from entry into the study to any cause of death Participants will be followed for at least 3 years after randomization
Secondary Progression-free survival Time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first Participants will be followed for at least 3 years after randomization
Secondary Post-operative complications The surgical complications will be evaluated at 30-day, 60-day, 90-day after upfront cytoreductive surgery or interval debulking surgery Participants will be followed up to 3 months after randomization
Secondary Quality of life assessments QLQ-C30, FACT-Q (baseline; 6 months, 12 months, 24 months and 36 months after randomization) Participants will be followed for at least 3 years after randomization
Secondary 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) Participants will be followed for at least 3 years or death after randomization
Secondary 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 Participants will be followed for at least 3 years or death after randomization
Secondary TSST Time from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurred first Participants will be followed for at least 3 years or death after randomization
Secondary 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. Participants will be followed for at least 3 years or death after randomization
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