Primary debulking surgery
ProcedurePrimary 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
NCT Number: NCT05200260
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 2
The First People's Hospital of Foshan, Foshan, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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.
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
Time frame: Participants will be followed for at least 3 years after randomization
Time from entry into the study to any cause of death
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
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
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)
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)
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
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
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.
Contact information is provided by the study sponsor or research team.
Shanghai Gynecologic Oncology Group
Other Gov
A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
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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