NCT04138992

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

October 23, 2019

Last Update Submit

June 28, 2020

Conditions

Disease Free Survival

Keywords

Bevacizumablocal advanced cervical cancerconcurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    disease free survival

    3 year

Secondary Outcomes (1)

  • local control

    3 year

Other Outcomes (2)

  • distant metastasis

    3 year

  • grade 3-4 side effects

    3 year

Study Arms (3)

study group A

EXPERIMENTAL

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: bevacizumabDrug: DDPDrug: DocetaxelRadiation: radiotherapy

study group B

EXPERIMENTAL

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: bevacizumabDrug: DDPRadiation: radiotherapy

control

ACTIVE COMPARATOR

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: DDPRadiation: radiotherapy

Interventions

bevacizumabDRUG

bevacizumab will be used during neoadjuvant and concurrent chemoradiotherapy

Also known as: Avastin
study group Astudy group B
DDPDRUG

DDP will be used during neoadjuvant and concurrent chemoradiotherapy

Also known as: Cisplatin
controlstudy group Astudy group B
DocetaxelDRUG

used in neoadjuvant chemotherapy

study group A
radiotherapyRADIATION

standard treatment includes pelvic external beam radiation and brachytherapy

Also known as: RT
controlstudy group Astudy group B

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • ， 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Links

MeSH Terms

Interventions

BevacizumabCisplatinDocetaxelRadiotherapy

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesTherapeutics

Study Officials

  • mei shi, M.D.

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lichun Wei, physician

CONTACT

029-84775432weilichun@fmmu.edu.cn

ying zhang, physician

CONTACT

029-84775432zhangying@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of department

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 25, 2019

Study Start

August 1, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2022

Last Updated

June 30, 2020

Record last verified: 2020-06

Locations

CN(1)