Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Docetaxel

Cisplatin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tubulin Modulators

Antimitotic Agents

bevacizumab combined with neoadjuvant chemotherapy and concurrent chemoradiotherapy：

1. bevacizumab combined with neoadjuvant chemotherapy for 2 cycles: Bevacizumab will be used as 7.5 mg/kg, once every three weeks; DDP 75mg/m2, intravenous injection，once three week; Docetaxel 75mg/m2, intravenous injection，once three week;
2. bevacizumab combined with concurrent chemoradiotherapy: Bevacizumab will be used as 7.5 mg/kg, once every three weeks; DDP 75mg/m2, intravenous injection，once three week pelvic radiotherapy will be delivered with 45-50Gy/25f; enlarged lymph nodes be irradiated by 62.5Gy/25f with sib-IMRT; brachytherapy be delivered to cervix and primary tumor

study arm: bevacizumab combined with concurrent chemoradiotherapy： Bevacizumab will be used as 7.5 mg/kg, once every three weeks; DDP 75mg/m2, intravenous injection，once three week; pelvic radiotherapy will be delivered with 45-50Gy/25f; enlarged lymph nodes be irradiated by 62.5Gy/25f with sib-IMRT; brachytherapy be delivered to cervix and primary tumor

standard concurrent chemoradiotherapy: DDP 40mg/m2, intravenous injection，once a week; pelvic radiotherapy will be delivered with 45-50Gy/25f; enlarged lymph nodes be irradiated by 62.5Gy/25f with sib-IMRT; brachytherapy be delivered to cervix and primary tumor

bevacizumab will be used during neoadjuvant and concurrent chemoradiotherapy

bevacizumab

DDP will be used during neoadjuvant and concurrent chemoradiotherapy

standard treatment includes pelvic external beam radiation and brachytherapy

radiotherapy

Lichun Wei, physician

ying zhang, physician

Lichun Wei, MD

Li-Chun Wei, M.D.,Ph.D

ying zhang, M.D.,Ph.D

hua yang, M.D.

jianping Li, M.D.,Ph.D

weiwei Li, M.D.

Lina Zhao, M.D.,Ph.D

Mei Shi, M.D.,Ph.D

mei shi, M.D.

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

A Study on the Efficacy and Safety of Bevacizumab in Untreated Patients With Locally Advanced Cervical Cancer

a Prospective Random Study on the Efficacy and Safety of Bevacizumab in Untreated Patients With Locally Advanced Cervical Cancer

Air Force Military Medical University, China

head of department

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study on the Efficacy and Safety of Bevacizumab in Untreated Patients With Locally Advanced Cervical Cancer	NCT04138992	Disease Free Su...	bevacizumab DDP Docetaxel radiotherapy	18 Years - 65 Years	Air Force Military Medical University, China
A Study on the Efficacy and Safety of Bevacizumab in Untreated Patients With Locally Advanced Cervical Cancer	NCT04138992	Disease Free Su...	bevacizumab DDP Docetaxel radiotherapy	18 Years - 65 Years	Air Force Military Medical University, China

Spots Global Cancer Trial Database for local advanced cervical cancer