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| ID | Type | Description | Link |
|---|---|---|---|
| SOC-2 | Other Identifier | Shanghai Gynecologic Oncology Group |
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The purpose of this study is to answer the fundamental question, should the physicians choose Surgery or Chemotherapy (SOC-2) in advanced ovarian cancer?
OBJECTIVES: Compare the efficacy and safety in patients with AJCC TNM stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer, or peritoneal carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront surgery.
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.
Patients are followed every 3 months within the first 5 years, and then every 6 months.
PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study within 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upfront cytoreductive surgery | Experimental | Upfront cytoreductive surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy. |
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| Neoadjuvant chemotherapy | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upfront cytoreductive surgery | Procedure | Upfront cytoreductive 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 | The time from entry into the study to any cause of death. | Participants will be followed for at least 5 years after randomization or until death |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first. | Participants will be followed for at least 5 years after randomization or until death |
| Post-operative complications |
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Inclusion Criteria:
Women aged ≥ 18 years.
Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or fine needle aspiration*). Laparoscopic biopsy with pictures is recommended.
* If fine needle aspiration showing an adenocarcinoma, patients should satisfy the following conditions: a. the patient has a pelvic mass, and b. omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis, and c. serum CA125/CEA ratio>25. If serum CA125/CEA ratio<25 or malignancies of other origins, such as breasts and digestive tract, are suspected from symptoms, physical examinations or imaging diagnosis, endoscopy or ultrasonography should be done to exclusive metastasis ovarian cancer.
ECOG performance status of 0 to 2.
ASA score of 1 to 2.
Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
Comply with the study protocol and follow-up.
Written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rongyu Zang, MD,PHD | Fudan University Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yet-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China | ||
| Zhongshan Hospital Fudan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32808504 | Derived | Jiang R, Zhu J, Kim JW, Liu J, Kato K, Kim HS, Zhang Y, Zhang P, Zhu T, Aoki D, Yu A, Chen X, Wang X, Zhu D, Zhang W, Jia H, Shi T, Gao W, Yin S, Feng Y, Xiang L, Okamoto A, Zang R. Study of upfront surgery versus neoadjuvant chemotherapy followed by interval debulking surgery for patients with stage IIIC and IV ovarian cancer, SGOG SUNNY (SOC-2) trial concept. J Gynecol Oncol. 2020 Sep;31(5):e86. doi: 10.3802/jgo.2020.31.e86. |
| Label | URL |
|---|---|
| Shanghai Gynecologic Oncology Group | View source |
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| Interval debulking surgery | 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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The surgical complications will be evaluated at 30-day after upfront cytoreductive surgery or interval debulking surgery. |
| Participants will be followed up to 6 months after randomization |
| Quality of life assessments | QOQ-C30,FACT-O( baseline; 6months, 12 months and 5 years after randomization) | Participants will be followed for at least 5 years after randomization or until death |
| Accumulated treatment-free survival (TFSa) | The overall survival time minus the total treatment time of surgery and chemotherapy after randomization, but maintenance of targeted agents is considered off-treatment. | Participants will be followed for at least 5 years after randomization or until death |
| Time to first subsequent anticancer therapy (TFST) | The date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurs first. Maintenance treatments following a cytostatic treatment are NOT considered separate treatment lines. | Participants will be followed for at least 5 years after randomization or until death |
| Time to second subsequent anticancer therapy (TSST) | The date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurs first. Maintenance treatments following a cytostatic treatment are NOT considered separate treatment lines. | Participants will be followed for at least 5 years after randomization or until death |
| 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 5 years after randomization or until death |
| The rate of 5-year progression-free survival | The rate of the patients without progression or recurrence or death at 5 years. | Participants will be followed for at least 5 years after randomization or until death |
| Outcomes of pulmonary embolism | The incidence of pulmonary embolism prior to primary treatment in the ITT and hospital populations. Its effect on survival between groups in the ITT and hospital populations. | Participants will be followed for at least 5 years after randomization or until death |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| Shanghai First Maternity and Infant Hospital Affiliated to Tongji University | Shanghai | Shanghai Municipality | 200040 | China |
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Hunan Provincial Hospital | Changsha | China |
| Seoul National University Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| 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 |
| 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 |
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