Disease Free Survival Clinical Trial
Official title:
a Prospective Random Study on the Efficacy and Safety of Bevacizumab in Untreated Patients With Locally Advanced Cervical Cancer
To verify the clinical efficacy and safety of bevacizumab in treating local advanced cervical cancer, present study was designed to investigate the clinical results of bevacizumab combined with concurrent chemoradiotherapy (CCRT) in local advanced cervical cancer
Cervical cancer is the most common malignant tumor of the female productive system in
developing countries and regions. Since five large-sample randomized controlled clinical
trials have reported that concurrent chemoradiotherapy can improve the survival rate of
patients with cervical cancer in the early 20th century, cisplatin-based concurrent
chemoradiotherapy has become the standard treatment for locally advanced cervical cancer
(LACC) . LACC has the characteristics of high invasiveness, high lymphatic metastasis and
poor prognosis. The size and stage of the tumor are two independent prognostic factors. In
2008, a retrospective study published in Journal of Clinical Oncology(JCO) suggested that
single-agent concurrent chemoradiotherapy did not improve disease-free survival (DFS) or
overall survival (OS) for patients with FIGO stage II-IVA tumors. Multiple studies reported
poor prognosis in patients with primary tumors whose diameters were larger than 4 cm, 5 cm or
6 cm , and in 2016, Fokdal. et al. reported a low local control rate if the residual tumor
volume was larger than 30 cc prior to afterloading brachytherapy . In the EMBRACE trial,
Jastaniyah et al. divided tumors into five groups based on the difference between the tumor
volume before treatment and prior to afterloading brachytherapy, and found that the dose
coverage of the HR-CTV by D90 was low for patients with a large primary tumor volume and a
poor treatment response [13]. Therefore, for patients with a large primary tumor volume,
further studies are required to investigate whether accelerated tumor volume regression prior
to afterloading brachytherapy is meaningful to escalating the local afterloading dose
delivered to tumor and improving the local control rate and OS.
In recent years, with the rapid development of molecular biology, there have been multiple
clinical trials regarding the molecular targeted drug therapy for tumor cell-specific targets
. The angiogenesis inhibitor, bevacizumab, is the first molecular targeted drug for recurrent
or advanced cervical cancer, which inhibits tumor angiogenesis by blocking the function of
the vascular endothelial growth factor (VEGF). In a GOG phase II clinical trial, bevacizumab
was applied to 46 patients with recurrent cervical cancer. The study reported a
progression-free survival (PFS) of more than 6 months, with a median PFS and a median OS of
3.50 months and 7.29 months, respectively. Another GOG240 phase III clinical trial showed
that chemotherapy combined with bevacizumab extended the OS of patients with recurrent and
metastatic cervical cancer. United States' NCCN Clinical Practice Guidelines recommend the
combined use of bevacizumab with paclitaxel + cisplatin for the first-line treatment of
current and metastatic cervical cancer. However, there is a lack of evidence for the use of
bevacizumab in the treatment of LACC.
The above background information raises the questions of: during the initial treatment of
LACC, can the introduction of bevacizumab improve the patient's tumor regression rate and OS?
And compared to concurrent chemoradiotherapy directly combined with bevacizumab, can
neoadjuvant chemotherapy combined with bevacizumab + concurrent chemoradiotherapy further
improve the therapeutic outcome? However, currently there is no research on these topics. In
2017, our research team reported poor prognosis in patients with LACC who had a high VEGFR
expression . This result indicated that anti-angiogenic therapy could benefit patients with
LACC. To investigate the clinical efficacy and safety of bevacizumab in treating local
advanced cervical cancer, we design this clinical study
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