Clinical trial NCT05200260: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Keywords: Ovarian Cancer
Primary Debulking Surgery
Neoadjuvant chemotherapy
Poly-adenosine Ribose Phosphate Inhbitors (PARPi)
Bevacizumab
Lead sponsor: Shanghai Gynecologic Oncology Group
Sponsor class: OTHER_GOV
Collaborators: name: Fudan University
First posted: 2022-01-20
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Bevacizumab or Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.

Eligibility criteria: 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.

Primary outcomes:
measure: 3-year overall survival
timeFrame: Participants will be followed for at least 3 years after randomization
Secondary outcomes:
measure: Overall survival
timeFrame: Participants will be followed for at least 3 years after randomization
measure: Progression-free survival
timeFrame: Participants will be followed for at least 3 years after randomization
measure: Post-operative complications
timeFrame: Participants will be followed up to 3 months after randomization
measure: Quality of life assessments
timeFrame: Participants will be followed for at least 3 years after randomization
measure: Accumulated treatment-free survival
timeFrame: Participants will be followed for at least 3 years or death after randomization
measure: TFST
timeFrame: Participants will be followed for at least 3 years or death after randomization
measure: TSST
timeFrame: Participants will be followed for at least 3 years or death after randomization
measure: The pattern of the first relapse
timeFrame: Participants will be followed for at least 3 years or death after randomization
Other outcomes:
Locations:
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Guangzhou
country: China
facility: Sun Yet-Sen University Cancer Center
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fundan University
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
affiliation: Fudan University
name: Libing Xiang
role: STUDY_CHAIR
References: