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| ID | Type | Description | Link |
|---|---|---|---|
| SGOG OV2 | Other Identifier | SGOG |
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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Zhejiang Cancer Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Sun Yat-sen University |
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The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian cancer.
The primary objective is to determine whether secondary cytoreduction followed by chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS) and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| secondary cytoreductive surgery | Experimental | SCR followed by chemotherapy |
|
| Salvage Chemotherapy | Active Comparator | platinum-based chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secondary Cytoreductive Surgery | Procedure | Complete Cytoreduction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | from date of randomisation until death | Up to 60 months after last patient randomized |
| Progression-free survival | interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first | Up to 24 months after last patient randomized |
| Measure | Description | Time Frame |
|---|---|---|
| Accumulating Treatment-free survival (TFSa) | the time of OS minus each treatment period after randomization, including surgery and chemotherapy | Up to 60 months after last patient randomized |
| Overall survival after the adjustment of one-way treatment switching |
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Inclusion Criteria:
Exclusion Criteria:
Patients with borderline tumors as well as non-epithelial tumors.
Patients for interval-debulking, or for second-look surgery, or palliative surgery planned.
Impossible to assess the resectability or evaluate the score. Radiological signs suggesting complete resection is impossible.
More than one prior chemotherapy.
Second relapse or more
Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
Progression during chemotherapy or recurrence within 6 months after first-line therapy
Any contradiction not allowing surgery and/or chemotherapy
Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents, or bevacizumab.
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| Name | Affiliation | Role |
|---|---|---|
| Rongyu Zang, MD,PhD | Shanghai Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China | ||
| Fudan University Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38824243 | Derived | Jiang R, Feng Y, Chen Y, Cheng X, Shi T, Gao W, Jia H, Jiang S, Guo Y, Huang X, Tu D, Zhang Y, Yang H, Zhang P, Liu J, Zhu J, Zang R; SOC-1 Investigators. Surgery versus no surgery in platinum-sensitive relapsed ovarian cancer: final overall survival analysis of the SOC-1 randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2181-2188. doi: 10.1038/s41591-024-02981-0. Epub 2024 Jun 1. | |
| 33705695 |
| Label | URL |
|---|---|
| Shanghai Gynecologic Oncology Group | View source |
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| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| OTHER |
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| Salvage Chemotherapy | Drug | 6 cycles of postoperative chemotherapy |
|
|
OS adjusted by statistical models for crossover |
| Up to 60 months after last patient randomized |
| 30-day post-operative complications | MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications | From the operation until after 30 days |
| Validation of iMODEL | iMODEL score to predict complete resection | From randomization to operation |
| Patient compliance | compliance with protocol | Up to 60 months after last patient randomized |
| Quality of life assessments | The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O) | Study entry; 6 months; 12 months; 24 months and 60 months after randomization |
| Time to first subsequent anticancer therapy | From date of randomization until the date of first recurrent anticancer therapy | Up to 60 months after last patient randomized |
| Time to second subsequent anticancer therapy | From date of randomization until the date of secondary recurrent anticancer therapy | Up to 60 months after last patient randomized |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| Shanghai Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Derived |
| Shi T, Zhu J, Feng Y, Tu D, Zhang Y, Zhang P, Jia H, Huang X, Cai Y, Yin S, Jiang R, Tian W, Gao W, Liu J, Yang H, Cheng X, Zang R. Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):439-449. doi: 10.1016/S1470-2045(21)00006-1. Epub 2021 Mar 8. |
| D005184 |
| Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |