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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05200260
• Other study ID #: SAT-1
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

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