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

ConditionsOvarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorShanghai Gynecologic Oncology Group

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Primary debulking surgery

    Procedure/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

    Procedure/Surgery

    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.

  • 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.

  • 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.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Upfront cytoreductive surgery with maintenance therapyExperimental treatment 3 interventions
Group B: Neoadjuvant chemotherapy with maintenance therapyActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

3-year overall survival

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

Secondary outcomes

1

Overall survival

Time from entry into the study to any cause of death

Time frame
Participants will be followed for at least 3 years after randomization
2

Progression-free survival

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 for at least 3 years after randomization
3

Post-operative complications

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 up to 3 months after randomization
4

Quality of life assessments

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 after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Gynecologic Oncology Group

Lead sponsor

Fudan University

Collaborator

Source ClinicalTrials.gov
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