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This study is an open-label, randomized study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node (PAN) and supraclavicular lymph nodes, and also on improving disease-free survival of locally advanced uterine cervical cancer. This study includes a translational research component in that all the primary tumors and lymph node are stained with Sema4c, before randomization. According to the investigators study result, patients with more pelvic lymph node metastasis are more likely to develop distant metastasis including the recurrences at PAN and supraclavicular lymph node. Primary cervical cancer tissues and lymph nodes are examined for expression of Sema4c just after registration, and before the patients are randomized to each arm (pelvis only vs. EFI). The investigators expect a higher benefit of EFI in patients with Sema4c-positive lymph node.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sema4c positive +Common iliac lymph nodes control | No Intervention | Sema4c Positive & "Radical hysterectomy +Pelvic Radiotherapy " | |
| Sema4c positive +Common iliac lymph nodes Experimental | Active Comparator | Sema4c Positive & "Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation) " |
|
| Sema4c Positive + PAN positive control arm | No Intervention | Sema4c Positive & " Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation) " | |
| Sema4c positive+ PAN positive Experimental | Experimental | Sema4c Positive & Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation+ supraclavicular lymph nodes irradiation) ' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic Irradiation of the Para-Aortic Lymph Nodes and supraclavicular lymph nodes in Locally Advanced Uterine Cervical Cancer | Radiation | Sema4c positive+ Para-aortic lymph node metastasis Experimental : Radiation: Extended-field Irradiation (EFI) Prophylactic irradiation of supraclavicular lymph node |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of the Extended-Field Irradiation on the recurrence rate in para-aortic lymph nodes, supraclavicular lymph nodes and the disease-free survival rate of the patients with locally advanced uterine cervical cancer | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate overall survival, toxicities and quality of life (QOL) of the patients treated by EFI compared to the control group of patients | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ma Ding, M.D. | Tongji Hospital of HUST | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital of HUST | Wuhan | Hubei | China |
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|
| Prophylactic Irradiation of the Para-Aortic Lymph Nodes and supraclavicular lymph nodes in Locally Advanced Uterine Cervical Cancer | Radiation | Sema4c positive +Common iliac lymph nodes metastasis Experimental :Radical hysterectomy+ EFI(whole pelvis + para-aortic lymph node irradiation) |
|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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