Laparoscopy Clinical Trial
Official title:
Neoadjuvant Chemotherapy Followed by Radical Hysterectomy for the Treatment of Locally Advanced Cervical Cancer: A Prospective Cohort Study
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.
n/a
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