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NCT Number: NCT05200260

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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.

Treatment and study plan

Primary debulking surgery

Procedure

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.

Other names: PDS

Neoadjuvant chemotherapy

Procedure

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.

Other names: Neoadjuvant chemotherapy followed by interval debulking surgery, NACT-IDS

PARP inhibitor

Drug

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.

Other names: Olaparib

Bevacizumab

Drug

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.

Primary outcomes

  1. 3-year overall survival

    Time frame: Participants will be followed for at least 3 years after randomization

    The proportion of patients alive at 3 years after entry into the study

Secondary outcomes

  1. Overall survival

    Time frame: Participants will be followed for at least 3 years after randomization

    Time from entry into the study to any cause of death

  2. Progression-free survival

    Time frame: Participants will be followed for at least 3 years after randomization

    Time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first

  3. Post-operative complications

    Time frame: Participants will be followed up to 3 months after randomization

    The surgical complications will be evaluated at 30-day, 60-day, 90-day after upfront cytoreductive surgery or interval debulking surgery

  4. Quality of life assessments

    Time frame: Participants will be followed for at least 3 years after randomization

    QLQ-C30, FACT-Q (baseline; 6 months, 12 months, 24 months and 36 months after randomization)

  5. Accumulated treatment-free survival

    Time frame: Participants will be followed for at least 3 years or death after randomization

    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)

  6. TFST

    Time frame: Participants will be followed for at least 3 years or death after randomization

    Time from the date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first

  7. TSST

    Time frame: Participants will be followed for at least 3 years or death after randomization

    Time from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurred first

  8. The pattern of the first relapse

    Time frame: Participants will be followed for at least 3 years or death after randomization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Libing Xiang

CONTACT

[email protected]

86 21 64041990 ext. 2801

Rong Jiang

CONTACT

[email protected]

86 21 64041990 ext. 2801

Sponsors and collaborators

Lead sponsor

Shanghai Gynecologic Oncology Group

Other Gov

Collaborators

  • Fudan University

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2022
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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