Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer

Conditions
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Cervical Carcinoma Stage IIB

Intervention / Treatment
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* Radiation: Concurrent chemoirradiation
* Drug: Paclitaxel
* Procedure: Radical Surgery
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly histologically confirmed cervical carcinoma Original clinical stage must be IIB （FIGO 2009） Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma Age between 18-65 Patients must give signed informed consent 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/mm3

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Concurrent chemoirradiation (CCRT)<br>Concurrent chemoirradiation | Radiation: Concurrent chemoirradiation<br>* External beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy<br>|
| Experimental: NACT+Surgery<br>Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery | Drug: Paclitaxel<br>* New adjuvant chemotherapy 3 cycles with Paclitaxel 150mg/m2 over 3 hours and Cisplatin<br>* Other names: NACT;Procedure: Radical Surgery<br>* Radical hysterectomy (Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling<br>* Other names: NACT and surgery;Drug: Cisplatin<br>* New adjuvant chemotherapy 3 cycles with Paclitaxel and Cisplatin 70mg/m2<br>* Other names: NACT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer, Stage IIB, Neoadjuvant chemotherapy