RECRUITINGPhase 2INTERVENTIONAL
Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
About This Trial
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
Who May Be Eligible (Plain English)
Who May Qualify:
- Females aged ≥ 18 years.
- Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
- Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination
- Complete cytoreduction can be achieved based on CT or PET/CT examination
- Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing
- Performance status (ECOG 0-2)
- 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, platelet count at least 100,000/µL, blood count (hemoglobin) at least 9 g/dL,
2. serum creatinine \<1.25 x upper normal limit (UNL) or kidney function (creatinine clearance) at least 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 willing to sign a consent form.
Who Should NOT Join This Trial:
- 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 olaparib/bevacizumab or its excipients
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).
- Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Females aged ≥ 18 years.
* Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
* Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination
* Complete cytoreduction can be achieved based on CT or PET/CT examination
* Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing
* Performance status (ECOG 0-2)
* 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 olaparib/bevacizumab or its excipients
* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).
* Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.
* Other conditions, such as religious, psychological, and other factors, that could interfere with the provision of informed consent, compliance to study procedures, or follow-up.
Treatments Being Tested
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.
PROCEDURE
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 BRCA mutated, maintenance therapy of PARP inhibitors following CR/PR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy.
DRUG
Bevacizumab
For patients without BRCA mutated, maintenance therapy of Bevacizumab following CR/PR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy.
Locations (9)
The First People's Hospital of Foshan
Foshan, China
Sun Yet-Sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
The First Affiliated Hospital of University of Science and Technology of China
Hefei, China
Fudan University Cancer Hospital
Shanghai, China
Obstetrics and Gynecology Hospital of Fundan University
Shanghai, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Zhongshan Hospital, Fudan University
Shanghai, China