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Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a hypothesis in terms of survival and treatment related morbidity.
Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIB cervical cancer are eligible for our study. They will receive cisplatin based neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or external beam radiation (EBRT) with concurrent weekly platinum 40mg/m2 followed by brachyradiotherapy (arm B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent chemoirradiation (CCRT) | Active Comparator | Concurrent chemoirradiation |
|
| NACT+Surgery | Experimental | Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent chemoirradiation | Radiation | External beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihong Liu, Ph. D | Contact | 86-20-87343102 | Liujih@mail.sysu.edu.cn | |
| He Huang, Ph. D | Contact | 86-20-87343014 | Huangh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jihong Liu, Ph. D | Sun Yat-Sen University Cancer Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32522771 | Derived | Tu H, Huang H, Ouyang Y, Liu Q, Xian B, Song K, Chen G, Shen Y, Liu J. Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study. Int J Gynecol Cancer. 2021 Jan;31(1):129-133. doi: 10.1136/ijgc-2020-001357. Epub 2020 Jun 9. |
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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 |
|---|---|
| D017239 | Paclitaxel |
| D013514 | Surgical Procedures, Operative |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel | Drug | New adjuvant chemotherapy 3 cycles with Paclitaxel 150mg/m2 over 3 hours and Cisplatin |
|
|
| Radical Surgery | Procedure | Radical hysterectomy (Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling |
|
|
| Cisplatin | Drug | New adjuvant chemotherapy 3 cycles with Paclitaxel and Cisplatin 70mg/m2 |
|
|
| 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 |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |