Cervical Cancer Clinical Trial
Official title:
Multicenter Study on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy With Cisplatin and Docetaxel Combined With Radiotherapy for Local Advanced Cervical Cancer
The standard treatment of local advanced cervical cancer is concurrent chemoradiotherapy. The 3 year disease free survival was about 50-70%. The distant metastasis is the main cause of failure in local advanced cervical cancer treated with 3-dimensional conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT). The purpose of this study is to investigate the efficacy and tolerance of concurrent and adjuvant chemotherapy with cisplatin and docetaxel for local advanced cervical cancer. It was expected that the 3 year disease free survival would be increased by 10% with this new treatment schedule.
The cervical cancer is the most common malignant gynecological tumor in the developing area.
From 1999, the concurrent chemoradiotherapy has been established as the standard treatment
for local advanced cervical cancer. The modern radiotherapy techniques, such as 3
dimensional conformal radiotherapy(3D-CRT), intensity modulated radiotherapy(IMRT), image
guided 3-dimensional brachytherapy(3D-BT), was widely used for the treatment of cervical
cancer. The recently clinical outcome showed that the 3 year local and regional control was
more than 90%［1-3］. The distant metastasis has proved to be the main cause of failure and
death, especially for the patient with pelvic lymph node metastasis, large volume of tumor
and advanced FIGO stage. the data showed that the 3 year distant metastasis free survival
and overall survival were 64.7% and 64.6% respectively for the patient with huge pelvic
lymph node metastasis and FIGO stage III- IVA. The system treatment pointing at the distant
metastasis has become to be the topic of clinical investigation.
Dueñas-González A`［4］ study demonstrated that the 3 year progress free survival and distant
metastasis free survival has increased by 8.9% and 8.3% by the radial radiotherapy combined
with concurrent chemotherapy with weekly gemcitabine and cisplatin and adjuvant chemotherapy
with triweekly gemcitabine and cisplatin. Ryu SY［5］ also reported the triweekly concurrent
cisplatin with 3 cycles improved survival outcomes compared with weekly concurrent
cisplatin. Retrospective studies by Tang and Jelavić-TB［6-7］ suggested that the adjubant
chemotherapy after CCRT has better DMFS and OS.
The aim of present study is to prospectively investigate the efficacy and safety of
concurrent and adjuvant chemotherapy with cisplatin and docetaxel for patients with local
advanced cervical cancer, especially for those with FIGO III-IVA with or without pelvic
lymph node metastasis and the FIGO IB2-IIB with pelvic lymph node metastasis.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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