Neoadjuvant Chemotherapy + Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Trial of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer(CSEM005)

Conditions
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PFS, OS, Quality of Life

Intervention / Treatment
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* Drug: NACT (Paclitaxel + Cisplatin or carboplatin)
* Procedure: radical surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly histologically confirmed cervical carcinoma; Histopathology squamaous carcinoma, adenocarcinoma or adeno-squamous carcinoma; Original clinical stage must be IB2 or IIA2 （FIGO); Age between 18-65; Patients must give signed informed consent; P.S status: 0-1; Estimated survival time > 3 months; Exclusion Criteria: The presence of uncontrolled life-threatening illness; Receiving other ways of anti-cancer therapy; Investigator consider the patients can't finish the whole study; With normal liver function test (ALT、AST>2.5×ULN); With normal renal function test (Creatinine>1.5×ULN); WBC<4,000/mm3 or PLT<100,000/mm; Accompany with other malignancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A(NACT)<br>Neoadjuvant Chemotherapy followed by Radical Surgery | Drug: NACT (Paclitaxel + Cisplatin or carboplatin)<br>* Paclitaxel 150mg/m2 over 3 hours + Cisplatin 70mg/m2 or carboplatin AUC = 6, repeat per 21 days, 3 cycles.<br>Procedure: radical surgery<br>* Radical hysterectomy (Piver Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling<br>|
| Active Comparator: B(RS)<br>Radical Surgery alone | Procedure: radical surgery<br>* Radical hysterectomy (Piver Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5 years | 
| quality of life |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoadjuvant chemotherapy, radical surgery, cervical carcinoma