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

Sponsor
Air Force Military Medical University, China
Study ID
NCT04138992
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Disease Free Survival

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    bevacizumab will be used during neoadjuvant and concurrent chemoradiotherapy
  • DDP — DRUG
    DDP will be used during neoadjuvant and concurrent chemoradiotherapy
  • Docetaxel — DRUG
    used in neoadjuvant chemotherapy
  • radiotherapy — RADIATION
    standard treatment includes pelvic external beam radiation and brachytherapy

Study Details

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

Key Dates

First listed
Oct 25, 2019
Start date
Aug 1, 2020
Status verified
Jun 2020
Primary completion
May 31, 2021
Completion
May 31, 2022

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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
  • 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

Primary Outcome Measure

disease free survival [ Time Frame: 3 year ]

Central Contacts