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To clarify the potential benefits of NACT before radical surgery(RS), we perform a phase III, randomised controlled trial to compare NACT plus RS with RS alone in patients with stages IB2 and IIA2 cervical cancer.
Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IB2 and IIA2 cervical cancer are eligible for our study. They will receive paclitaxel + cisplatin(TP)/carboplatin(TC) regimen neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or directly radical surgery (arm B). Postoperative pelvic radiotherapy will be started within 6 weeks after surgery if the patients have pelvic lymph node metastasis, parametrial involvement, deep stromal invasion or positive margin. Extended-field external beam therapy, delivering a dose of 4500cGy by a four-field technique, will be administered to patients with positive para-aortic nodes. High-dose rate brachytherapy will be delivered to the vaginal stump if patients have positive surgical margins. The primary end point is 2-years progression-free survival, The secondary end points is overall survival , rate of response to TP or TC regimen chemotherapy and the quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A(NACT) | Experimental | Neoadjuvant Chemotherapy followed by Radical Surgery |
|
| B(RS) | Active Comparator | Radical Surgery alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NACT (Paclitaxel + Cisplatin or carboplatin) | Drug | Paclitaxel 150mg/m2 over 3 hours + Cisplatin 70mg/m2 or carboplatin AUC = 6, repeat per 21 days, 3 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 5 years | |
| quality of life | 3 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 | |
| Ting Wan, Ph. D | Contact | 86-20-87343014 | wanting@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jihong Liu, Ph.D | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center, Department of Gynecologic Oncology | Recruiting | Guangzhou | Guangdong | 510060 | 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 |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| radical surgery | Procedure | Radical hysterectomy (Piver Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling |
|
| 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 |
| D056831 | Coordination Complexes |