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Cervical cancer of early stage is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events of radical resection. The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, for incidence of adverse events and local recurrence rate.
Background
Cervical Cancer is one of the most common malignant tumors of Chinese females. The early stage diseases (Stage Ia, Ib and IIa1) is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events (incidence 18-35%) of radical resection. When adjuvant radiotherapy (ART) is performed, lymphocyst is included in the clinical target volume (CTV) with a dose of 45-50Gy, in most hospitals of China. However, there is no pathologic and clinical evidence that lymphocyst is associated with local recurrence. However, inclusion of lymphocyst might enlarge CTV and increase irradiation dose of organs at risk (OARs) such as small intestine and kidneys.
Objective
The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, for incidence of adverse events and local recurrence rate.
Patients and methods
A patient will be enrolled when patient have:
Randomization is performed to divide the patients into the control group (Group A) and the experimental group (Group B). In Group A, the CTV includes all the lymphocyst. But in Group B, the CTV is delineated according to the lymph drainage pathway (not all the lymphocyst included). ART is performed with a dose of 60Gy to the gross tumor volume, and 45Gy to the CTV. Chemotherapy is given concurrently with cisplatin 30mg/m2 every week regimen. The Grade 3/4 adverse events (CTCAE criteria ver. 4.03) and the 5-year local-recurrence-free survival of the 2 groups are compared after 5-year follow-up with an interval of 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The control group (Group A) | Active Comparator | In Group A, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method A. The regimen of chemotherapy is cisplatin 30mg/m2 every week. |
|
| The experiment group (Group B) | Experimental | In Group B, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method B. The regimen of chemotherapy is cisplatin 30mg/m2 every week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Method B | Radiation | The gross tumor volume (GTV) is the residual lesion after radical resection and given a dose of 60Gy. The clinical target volume (CTV) is delineated according to the lymph drainage pathway and included all the lymphocyst. The CTV is given a dose of 45Gy. |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year local-recurrence-free survival (5y-LRFS) | Percentage of patients in a treatment group who are alive without local recurrence for a 5-year period of follow-up after the date of radiotherapy completion | 5 years after the date of radiotherapy completion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade 3/4 adverse event | Incidence of patients in a treatment group who manifest a specific adverse event (such as myelosuppression) of grade 3/4. Incidence is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) criteria ver. 4.03. | Once a week during therapy, up to 5 years after the date of radiotherapy completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-jun Ye, M.D | Contact | 86-13538799871 | yewj@sysucc.org.cn | |
| Hui Chang, M.D | Contact | 86-13480295989 | changhui@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wei-jun Ye, M.D | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Affiliated Foshan Hospital | Not yet recruiting | Foshan | Guangdong | 528000 | China |
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|
| Cisplatin | Drug | The regimen of chemotherapy is cisplatin 30mg/m2 every week. |
|
| Radiation Method A | Radiation | The gross tumor volume (GTV) is the residual lesion after radical resection and given a dose of 60Gy. The clinical target volume (CTV) is delineated according to the lymph drainage pathway and given a dose of 45Gy. |
|
| 5-year overall survival (5y-OS) | Percentage of patients in a treatment group who are alive for a 5-year period of follow-up after the date of radiotherapy completion | 5 years after the date of radiotherapy completion |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| The First affiliated Hospital of Guangdong Pharmaceutical University | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
|
| Guangzhou First People's Hospital | Not yet recruiting | Guangzhou | Guangdong | 510180 | China |
|
| Hospital of of Guangdong Armed Police Corps | Not yet recruiting | Guangzhou | Guangdong | 510507 | China |
|
| The People's Hospital of Guangxi Zhuang Autonomous Region | Not yet recruiting | Nanning | Guangxi | 530021 | China |
|
| Hainan General Hospital | Not yet recruiting | Haikou | Hainan | 570311 | China |
|
| Xinjiang Medical University Affiliated Tumor Hospital | Not yet recruiting | Ürümqi | Xinjiang | 830000 | China |
|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D008210 | Lymphocele |
| 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 |
| D003560 | Cysts |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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