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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
| Beijing Chao Yang Hospital |
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This study is a registration study.The main research: the curative effect of neoadjuvant chemotherapy in the treatment of â… B2 and â…¡A2 locally advanced cervical cancer.Research group: the neoadjuvant chemotherapy in combination with cervical cancer radical hysterectomy.Control group:cervical cancer radical hysterectomy directly.Main observation indexes is overall survival and disease-free survival.
This study is a multicenter registered study.Selected January 1, 2009 to June 31,2016 ,accepted neoadjuvant chemotherapy combined radical surgery or radical surgery directly as treatment,â… B2 and â…¡A2 stage cervical cancer patients at each center to participate in research. Total number of patients is at least 1000 cases.On January 1, 2009 to May 31, 2015 ,collected the baseline data and follow-up information of hospitalized patients ,called a retrospective group.On June 1,2015 to May 31,2016,all the cases into the group take prospective way to collect baseline data (called a prospective group).Mainly collect the follow-up information.
1.The main observation indexes: the overall survival (OS) : the time from treatment for the first time (first day of neoadjuvant chemotherapy or surgery) calculation to the time of death or the time of the last follow-up still alive(about four year).
2.Secondary outcome:
Subject of supervision organization for clinical research institute is Peking University Clinical Research Institute.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | 2009 FIGO staging â… B2 or â…¡A2,the treatment is neoadjuvant chemotherapy combined with cervical cancer radical surgery . |
| |
| control group | 2009 FIGO staging â… B2 or â…¡A2,the treatment is cervical cancer radical surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemotherapy | Procedure | There is no uniform schemer,commonly used drugs including carboplatin,cisplatin,paclitaxel,vincristine,bleomycin,fluorouracil,ifosfamide,mitomycin,gemcitabine,and so on.Methods including intravenous chemotherapy and artery intervention chemotherapy,also has not been unified. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | The time from treatment for the first time (first day of neoadjuvant chemotherapy or surgery) calculation to the time of death or the time of the last follow-up(In December 2019) still alive. | The average time is up to four year. |
| Measure | Description | Time Frame |
|---|---|---|
| 3 year disease-free survival (DFS) | From the operation time or neoadjuvant chemotherapy time calculation for the first time to recurrence/the time of death or the last follow-up time. | The average time is up to three year. |
| Measure | Description | Time Frame |
|---|---|---|
| the quality of life assessment | Including EQ-5D health index scale and FSFI scale. | Before treatment and follow-up period.The average time is up to two year. |
| High risk factors of relapse analysis | The high risk factors of relapse contain:lymgh node positive rate, cervical local tumor changes after neoadjuvant chemotherapy, pathologic complete response rate neoadjuvant chemotherapy, tumor pathology classification, tumor stromal infiltration depth, Cut edge positive rate, Vascular tumor emboli rate, etc. |
Inclusion Criteria:
Exclusion Criteria:
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2009 FIGO clinical staging IB2, IIA2 stage cervical cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu M Wu, professor | Contact | 13701016571 | wym597118@163.com | |
| Qun Zhao, Physician | Contact | 18600964126 | qunzhao02@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu M Wu, professor | Beijing obstetrics and geynecology hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Obstetrics and Gynecology Hospital, Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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| OTHER |
| Beijing Anzhen Hospital | OTHER |
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
| Peking University People's Hospital | OTHER |
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frozen tissue and (or) whole blood
|
| We get the result after operation.The average time is up to one year. |
| perioperative indexes | The perioperative indexes contain operation time, intraoperative blood loss, postoperative complications, postoperative mortality, etc. | The period of preoperative, intraoperative and postoperative.The average time is up to one year. |
| Adverse reactions | Application WHO anti-cancer drug adverse reaction degree and RTOG/EORTC criteria to evaluate different treatment of adverse reactions. | The period of neoadjuvant chemotherapy and postoperative radiotherapy and chemotherapy.The average time is up to one year. |
| 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 |