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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Patients in group A don't receive neoadjuvant chemotherapy |
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| Group B | Experimental | Patients in group B receive neoadjuvant chemotherapy and achieve imaging response |
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| Group C | Experimental | Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept concurrent chemoradiotherapy |
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| Group D | Experimental | Patients in group B receive neoadjuvant chemotherapy but don't achieve imaging response, and they accept radical hysterectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two cycles of neoadjuvant chemotherapy | Drug | Two cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li, M.D. | Contact | +8613911988831 | lileigh@163.com | |
| Lei Li, M.D. | Contact | +8613911988831 | lilei@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lei Li, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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patients diagnosed with locally advanced cervical cancer of stage IB2 to IIB (FIGO 2009 system)
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| First imaging evaluation | Diagnostic Test | First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET) |
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| Second imaging evaluation | Diagnostic Test | Second imaging evaluation consists of pelvic magnetic resonance imaging |
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| The third cycles of neoadjuvant chemotherapy | Drug | The third cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). |
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| RH | Procedure | Radical hysterectomy |
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| Radiochemotherapy | Radiation | Concurrent radiochemotherapy |
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| Pathologic evaluation | Diagnostic Test | Pathologic evaluation for RH patients |
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| 3 years |
| Severe adverse events | Severe adverse events of neoadjuvant chemotherapy | 1 year |
| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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