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| ID | Type | Description | Link |
|---|---|---|---|
| SOC-4 | Registry Identifier | Shanghai Gynecologic Oncology Group | |
| SGOG-OV6 | Registry Identifier | Shanghai Gynecologic Oncology Group |
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| Name | Class |
|---|---|
| Obstetrics & Gynecology Hospital of Fudan University | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai First Maternity and Infant Hospital | OTHER |
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The purpose of this study is to answer the fundamental question 'The Optimal Timing of Surgery' in advanced ovarian cancer patients with different tumor burden, and to perform translational study.
OBJECTIVES: Compare the efficacy and safety in patients with advanced ovarian cancer treated with NACT-IDS versus PDS, among different tumor burden groups. Compare survival benefit of PARPi therapy in patients treated with PDS or NACT-IDS.
OUTLINE: This is a randomized phase III multicenter study. Patients will receive upfront maximal cytoreductive surgery followed by at least 6 cycles of adjuvant chemotherapy or 3 cycles of neoadjuvant chemotherapy followed by interval debulking surgery, and then at least 3 cycles of adjuvant chemotherapy, and maintenance therapy of PARP inhibitor for patients with gBRCA/sBRCA mutation who had a complete or partial clinical response after platinum-based chemotherapy. Patients are followed every 3 months within the first 5 years, and then every 6 months.
PROJECTED ACCRUAL: A total of 410 patients will be accrued for this study within 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Arm I (low/medium tumor burden) | 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 gBRCA/sBRCA mutation, CR/PR after platinum-based therapy. |
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| Part 1 Arm II (low/medium tumor burden) | 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 gBRCA/sBRCA mutation, CR/PR after platinum-based therapy. |
|
| Part 2 Arm I (high tumor burden) | 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 gBRCA/sBRCA mutation, CR/PR after platinum-based therapy. |
|
| Part 2 Arm II (high tumor burden) | 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 gBRCA/sBRCA mutation, CR/PR after platinum-based therapy. |
| 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 |
|---|---|---|
| Overall survival | Time from randomization to the date of death from any cause or date of last contact | Participants will be followed for at least 5 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Time from randomization to the date of first progressive disease or death, whichever occurs first or date of last contact | Participants will be followed for at least 2 years after randomization |
| Post-operative complications |
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For Part 1:
Inclusion Criteria:
Females aged ≥ 18 years.
Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or core needle biopsy*, laparoscopic biopsy is not recommended). * If core needle biopsy could not be performed, patients should satisfy the following conditions:
cPCI score ≤ 8.
Performance status (ECOG 0-2).
Good ASA score (1/2).
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:
For Part 2:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Shen, MD | Contact | 86 21 64041990 | shen.lina@zs-hospital.sh.cn | |
| Tingyu Luan | Contact | 86 21 64041990 | luan.yuting@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China | ||
| Obstetrics & Gynecology Hospital of Fundan University |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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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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| PARPi | Drug | For patients with gBRCA/sBRCA mutation and CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors. |
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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 | Quality of life (Qol) as measured by QOQ-C30 | Participants will be followed for at least 12 months or death after randomization, whichever came first |
| Quality of life assessments | Quality of life (Qol) as measured by FACT-O | Participants will be followed for at least 12 months or death after randomization, whichever came first |
| Accumulating treatment-free survival | The overall survival time minus the total treatment time of surgery and chemotherapy after randomization, regardless of the targeted therapy | Participants will be followed for at least 5 years or death after randomization, whichever came first |
| Time to first subsequent anticancer therapy | Time from the date of randomization to the starting date of the first subsequent anticancer therapy or death, whichever occurs first or date of last contact | Participants will be followed for at least 2 years or death after randomization, whichever came first |
| Time to secondary subsequent anticancer therapy | Time from the date of randomization to the starting date of the second subsequent anticancer therapy or death, whichever occurs first or date of last contact | Participants will be followed for at least 5 years or death after randomization, whichever came first |
| Progression-free survival 2 | Time from randomization to second progressive disease or death, which occurs first or date of last contact | Participants will be followed for at least 5 years or death after randomization, whichever came first |
| Shanghai |
| China |
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| Shanghai First Maternity and Infant Hospital | Shanghai | China |
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| Shanghai Jiao Tong University School of Medicine Xinhua Hospital | Shanghai | China |
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| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |