NAC Followed by RH for the Treatment of LACC

Study Overview
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Brief Summary
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This cohort study is to evaluate the role of neoadjuvant chemotherapy (NAC) in the treatment of locally advanced cervical cancer (LACC). Sixty patients with LACC (FIGO 2009 stage IB2 to IIB) will be enrolled. After informed consents, they would accept the imaging evaluation of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET). After excluding cases of distant metastasis, they will accept two cycles of NAC (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). Then a second MRI is performed to evaluate the imaging response. For patients achieving objective response, radical hysterectomy (RH, via laparoscopy or laparotomy) and an evaluation of pathologic response are performed. For patients without objective imaging response, the choice of concurrent chemoradiotherapy or radical hysterectomy will be discussed. After RH, adjuvant therapy will be given according to the RH pathologic results. The primary objectives consist of (1) the objective imaging response after NAC; (2) the objective pathologic response after RH. The secondary objectives consist of (1) disease-free survival and overall survival after various therapy modalities; (2) severe adverse effects of NAC; (3) the effects of NAC on the surgical outcomes.

Official Title
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Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study

Conditions
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Neoadjuvant Chemotherapy, Locally Advanced Cervical Cancer, Radical Hysterectomy, Objective Response, Laparoscopy, Laparotomy, Concurrent Chemoradiotherapy, Adjuvant Therapy, Systematic Chemotherapy

Intervention / Treatment
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* Drug: Two cycles of neoadjuvant chemotherapy
* Diagnostic Test: First imaging evaluation
* Diagnostic Test: Second imaging evaluation
* Drug: The third cycles of neoadjuvant chemotherapy
* Procedure: RH
* Radiation: Radiochemotherapy
* Diagnostic Test: Pathologic evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix FIGO stage IB2 to IIB Type II or III radical hysterectomy or trachelectomy Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1 Aged 18 years to 45 years Well cardiopulmonary, liver and kidney functions for neoadjuvant chemotherapy Signed an approved informed consents Exclusion Criteria: Not satisfying any of the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: patients diagnosed with locally advanced cervical cancer of stage IB2 to IIB (FIGO 2009 system)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients in group A don't receive neoadjuvant chemotherapy | Diagnostic Test: First imaging evaluation<br>* First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)<br>Radiation: Radiochemotherapy<br>* Concurrent radiochemotherapy<br>|
| Experimental: Group B<br>Patients in group B receive neoadjuvant chemotherapy and achieve imaging response | Drug: Two cycles of neoadjuvant chemotherapy<br>* Two cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).<br>Diagnostic Test: First imaging evaluation<br>* First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)<br>Diagnostic Test: Second imaging evaluation<br>* Second imaging evaluation consists of pelvic magnetic resonance imaging<br>Drug: The third cycles of neoadjuvant chemotherapy<br>* The third cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).<br>Procedure: RH<br>* Radical hysterectomy<br>Diagnostic Test: Pathologic evaluation<br>* Pathologic evaluation for RH patients<br>|
| Experimental: Group C<br>Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy | Drug: Two cycles of neoadjuvant chemotherapy<br>* Two cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).<br>Diagnostic Test: First imaging evaluation<br>* First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)<br>Diagnostic Test: Second imaging evaluation<br>* Second imaging evaluation consists of pelvic magnetic resonance imaging<br>Radiation: Radiochemotherapy<br>* Concurrent radiochemotherapy<br>|
| Experimental: Group D<br>Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy | Drug: Two cycles of neoadjuvant chemotherapy<br>* Two cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).<br>Diagnostic Test: First imaging evaluation<br>* First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)<br>Diagnostic Test: Second imaging evaluation<br>* Second imaging evaluation consists of pelvic magnetic resonance imaging<br>Procedure: RH<br>* Radical hysterectomy<br>Diagnostic Test: Pathologic evaluation<br>* Pathologic evaluation for RH patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective pathologic response | Objective pathologic response for patients with radical hysterectomy | 3 years | 
| Objective imaging response | Objective imaging response for patients with neoadjuvant chemotherapy | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Disease-free survival for patients with various therapy modalities | 3 years | 
| Overall survival | Overall survival for patients with various therapy modalities | 3 years | 
| Severe adverse events | Severe adverse events of neoadjuvant chemotherapy | 1 year |