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| Name | Class |
|---|---|
| Fudan University | OTHER |
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Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upfront cytoreductive surgery with maintenance therapy | Experimental | Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ). |
|
| Neoadjuvant chemotherapy with maintenance therapy | Active Comparator | Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival | The proportion of patients alive at 3 years after entry into the study | Participants will be followed for at least 3 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from entry into the study to any cause of death | Participants will be followed for at least 3 years after randomization |
| Progression-free survival | Time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first |
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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:
Comply with the study protocol and follow-up.
Patients who have given their written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Libing Xiang | Contact | 86 21 64041990 | 2801 | xiang.libing@zs-hospital.sh.cn |
| Rong Jiang | Contact | 86 21 64041990 | 2801 | jiang.rong@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Libing Xiang | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People's Hospital of Foshan | Recruiting | Foshan | China |
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|
| 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. |
|
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| 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. |
|
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| 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. |
|
| Participants will be followed for at least 3 years after randomization |
| Post-operative complications | The surgical complications will be evaluated at 30-day, 60-day, 90-day after upfront cytoreductive surgery or interval debulking surgery | Participants will be followed up to 3 months after randomization |
| Quality of life assessments | QLQ-C30, FACT-Q (baseline; 6 months, 12 months, 24 months and 36 months after randomization) | Participants will be followed for at least 3 years after randomization |
| Accumulated treatment-free survival | 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) | Participants will be followed for at least 3 years or death after randomization |
| TFST | Time from the date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first | Participants will be followed for at least 3 years or death after randomization |
| TSST | Time from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurred first | Participants will be followed for at least 3 years or death after randomization |
| The pattern of the first relapse | 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. | Participants will be followed for at least 3 years or death after randomization |
| Sun Yet-Sen University Cancer Center | Recruiting | Guangzhou | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | China |
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| The First Affiliated Hospital of University of Science and Technology of China | Recruiting | Hefei | China |
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| Fudan University Cancer Hospital | Recruiting | Shanghai | China |
|
| Obstetrics and Gynecology Hospital of Fundan University | Recruiting | Shanghai | China |
|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | China |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D000067856 | Poly(ADP-ribose) Polymerase Inhibitors |
| C531550 | olaparib |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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