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| Name | Class |
|---|---|
| Fudan University | OTHER |
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The purpose of this study is to evaluate the safety and the effectiveness of hepato-celiac lymphadenectomy in the treatment of primarily diagnosed advanced epithelial ovarian cancer and platinum-sensitive recurrent ovarian cancer.
This single-arm, multi-center, phase II trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepato-celiac lymphadenectomy | Experimental | This single-arm, multi-center, phase II trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepato-celiac lymphadenectomy | Procedure | Hepato-celiac lymphadenectomy in the treatment of epithelial ovarian cancer, with a maximum cytoreduction, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy). |
| Measure | Description | Time Frame |
|---|---|---|
| 2-years Non-Progression Rate | The proportion of patients without disease progression or death at 2 years after entry into the study. | Participants will be followed up to 2 years after randomization |
| 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 up to 24 months after randomization |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Libing Xiang | Contact | 862164041990 | 2801 | xiang.libing@zs-hospital.sh.cn |
| Rong Jiang | Contact | 86 21 64041990 | 2801 | jiang.rong@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Rongyu Zang | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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The time from date of randomization until the date of death from any cause or last follow-up
| Participants will be followed up to 60 months after randomization |
| Objective response rate | The proportion of patients who achieved complete response (CR) or partial response (PR) | Participants will be followed up to 24 months after randomization |
| Disease control rate | The proportion of patients who achieved complete response (CR) or partial response (PR) or stable disease (SD) | Participants will be followed up to 24 months after randomization |
| Post-operative complications | Postoperative 30-day, 60-day and 90-day complications | Participants will be followed up to 90 days after randomization |
| Quality of life assessments (QLQ-C30) | Assessment of potential impact of first line treatment on functionality and well-being in patients by the EORTC core quality of life questionnaire (QLQ-C30, version 3.0). | Baseline; 6 months, 12 months and 24 months after randomization |
| Quality of life assessments (FACT-Q) | Assessment of potential impact of first line treatment on functionality and well-being in patients by functional assessment of cancer therapy-ovary (FACT-O, version 4). | Baseline; 6 months, 12 months and 24 months after randomization |
| Patterns of subsequent recurrence | The number and sites of subsequent recurrence, including pelvic, abdominal, retroperitoneal lymph nodes, hepato-celiac lymph nodes and distant metastases and ascites, etc. | Participants will be followed up to 24 months after randomization |
| 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 |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |