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Study on the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia During Concurrent Chemoradiotherapy of Cervical Cancer

NCT04542356 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-09-06

No results posted yet for this study

Summary

This randomized controlled prospective study aims to explore the efficacy and safety of using (PEGylated Recombinant Human Granulocyte Stimulating Factor) PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. To find out the best time to use PEG-rhG CSF, and to explore investigate the effect of PEG-rhG-CSF on long-term bone marrow function in the process of concurrent chemoradiotherapy, and finally to explore the clinical feasibility of using PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of TP regimen for cervical cancer.

Conditions

Interventions

DRUG

PEG-rhG-CSF

During the concurrent chemoradiotherapy, a single subcutaneous injection of 6 mg PEG-rhG-CSF was given to the patient 2 hours after radiotherapy on the first day after the end of chemotherapy. Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.

DRUG

rhG-CSF

Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.

Sponsors & Collaborators

  • Chongqing University Cancer Hospital

    lead OTHER

Principal Investigators

  • Dongling Zou, M.D. · Chongqing University Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2021-01-26
Completion
2021-05-26

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04542356 on ClinicalTrials.gov