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

June 28, 2020 updated by: Mei Shi, Air Force Military Medical University, China

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
        • Contact:
        • Principal Investigator:
          • Li-Chun Wei, M.D.,Ph.D
        • Sub-Investigator:
          • ying zhang, M.D.,Ph.D
        • Sub-Investigator:
          • hua yang, M.D.
        • Sub-Investigator:
          • jianping Li, M.D.,Ph.D
        • Sub-Investigator:
          • weiwei Li, M.D.
        • Principal Investigator:
          • Lina Zhao, M.D.,Ph.D
        • Principal Investigator:
          • Mei Shi, M.D.,Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
  2. 2018FIGO clinical stage I-IIIC disease

Exclusion Criteria:

1， Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; 2， Prior systemic chemotherapy within the past three years; 3， Prior radiotherapy to the pelvis or abdomen ; 4， Distant metastasis; 5， Severe, active co-morbidity; 6， patients with FIGO stage IVA 7， Bevacizumab is prohibited to the patients with active bleeding and hypertension

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: study group A

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
Drug: bevacizumab
bevacizumab will be used during neoadjuvant and concurrent chemoradiotherapy
Other Names:
  • Avastin
Drug: DDP
DDP will be used during neoadjuvant and concurrent chemoradiotherapy
Other Names:
  • Cisplatin
Drug: Docetaxel
used in neoadjuvant chemotherapy
Radiation: radiotherapy
standard treatment includes pelvic external beam radiation and brachytherapy
Other Names:
  • RT
Experimental: study group B
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
Drug: bevacizumab
bevacizumab will be used during neoadjuvant and concurrent chemoradiotherapy
Other Names:
  • Avastin
Drug: DDP
DDP will be used during neoadjuvant and concurrent chemoradiotherapy
Other Names:
  • Cisplatin
Radiation: radiotherapy
standard treatment includes pelvic external beam radiation and brachytherapy
Other Names:
  • RT
Active Comparator: control
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
Drug: DDP
DDP will be used during neoadjuvant and concurrent chemoradiotherapy
Other Names:
  • Cisplatin
Radiation: radiotherapy
standard treatment includes pelvic external beam radiation and brachytherapy
Other Names:
  • RT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
disease free survival
Time Frame: 3 year
disease free survival
3 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
local control
Time Frame: 3 year
local control
3 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
distant metastasis
Time Frame: 3 year
distant metastasis
3 year
grade 3-4 side effects
Time Frame: 3 year
grade 3-4 side effects
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Air Force Military Medical University, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: mei shi, M.D., Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJFL-2019-01-LACC-bevacizumab

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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