Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

February 16, 2023 updated by: Fourth Affiliated Hospital of Guangxi Medical University

A Prospective Randomized Controlled Trial for Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy in the Treatment of Advanced Cervical Cancer at 2018 FIGO Staging

This study carried out a prospective, randomized, controlled clinical study under the background of intensity-modulated radiation therapy and three-dimensional afterloading therapy. By comparing simultaneous intensity-modulated radiotherapy and chemotherapy combined with adjuvant chemotherapy and simultaneous intensity-modulated radiotherapy and chemotherapy alone, based on the 2018 FIGO staging The clinical efficacy of locally advanced cervical cancer further clarifies the role of adjuvant chemotherapy in locally advanced cervical cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Concurrent chemoradiotherapy is the standard treatment for locally advanced cervical cancer, but there are still many patients with local recurrence or metastasis after treatment, and the 5-year survival rate is low. Concurrent chemoradiotherapy followed by adjuvant chemotherapy for locally advanced cervical cancer is still controversial in improving disease-free survival and overall survival, and previous studies were mostly based on traditional two-dimensional radiotherapy techniques, intensity-modulated radiotherapy and three-dimensional afterloading in dosimetry and radiotherapy. Compared with traditional radiotherapy, it has more advantages in terms of biological effects. In addition, after the adjustment of the new 2018 FIGO staging, it is possible to change the impact of the original treatment mode on overall survival. Therefore, more evidence-based medical evidence is needed to clarify the clinical value of adjuvant chemotherapy in the treatment of locally advanced cervical cancer. Therefore, this study carried out a prospective, randomized, controlled clinical study under the background of intensity-modulated radiation therapy and three-dimensional afterloading therapy. By comparing simultaneous intensity-modulated radiotherapy and chemotherapy combined with adjuvant chemotherapy and simultaneous intensity-modulated radiotherapy and chemotherapy alone, based on the 2018 FIGO staging The clinical efficacy of locally advanced cervical cancer further clarifies the role of adjuvant chemotherapy in locally advanced cervical cancer.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • 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 Backup

  • Name: Feng chengjun
  • Phone Number: 18877279562
  • Email: leymj@163.com

Study Locations

  • China
    • Guangxi
      • Liuzhou, Guangxi, China, 545005
        • Recruiting
        • The Fourth Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Chengjun Feng, Master
          • Phone Number: +86 18877279562
          • Email: leymj@163.com

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Cervical cancer confirmed by histopathology incloud squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma
  • FIGO stage IB3, IIA2, IIB-IVA patients in 2018
  • Locally advanced cervical cancer patients received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment after diagnosis, and the effect reached CR after treatment
  • Aged 18-75 years
  • PS score 0-1
  • Serum hemoglobin >=100*10^9/L, blood platelet >= 100000/μL, absolute count of neutrophils>=1500/μL; 7.Serum creatinine <=1.5 UNL or creatinine clearance >= 60 ml/min; 8.Serum bilirubin <=1.5 UNL, AST (SGOT) and ALT (SGPT)<= 1.5 UNL
  • Sign a formal informed consent to show that they understand that the study is in line with hospital and national policies .Estimated total survival > 6 months.

Exclusion Criteria:

  • Locally advanced cervical cancer patients received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment after diagnosis, and the effect unreached CR after treatment
  • Patients who have received neoadjuvant chemotherapy and surgery
  • Patients with cognitive impairment
  • Patients with any distant metastases
  • Patients with any other malignancy within 5 years
  • Any other disease or condition is contraindications to chemoradiotherapy (e.g., active infection, 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive therapy, etc.); 5.Pregnant or lactating women, or fertile women who do not use contraception
  • Severe bone marrow dysfunction
  • Patients with bleeding tendency
  • Drug abusers or alcohol addicts
  • Those who are known to have a third or fourth degree allergic reaction to any treatment in the study

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: concurrent chemoradiotherapy combined with adjuvant chemotherapy
Adjuvant chemotherapy in patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy
Drug: paclitaxel combined with platinum
Adjuvant chemotherapy with paclitaxel combined with platinum
Other Names:
  • Adjuvant chemotherapy with paclitaxel combined with platinum
Other: concurrent chemoradiotherapy
Observation of patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy
Drug: paclitaxel combined with platinum
Adjuvant chemotherapy with paclitaxel combined with platinum
Other Names:
  • Adjuvant chemotherapy with paclitaxel combined with platinum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Refers to the time from randomization to the first occurrence of disease progression or death from any cause，whichever came first, assessed up to 1000 months
progression-free survival
Refers to the time from randomization to the first occurrence of disease progression or death from any cause，whichever came first, assessed up to 1000 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: Refers to the time from randomization to death from any cause, assessed up to 1000 months
Overall survival
Refers to the time from randomization to death from any cause, assessed up to 1000 months

Collaborators and Investigators

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

Sponsor

Fourth Affiliated Hospital of Guangxi Medical University

Investigators

  • Principal Investigator: Feng chengjun, The The Fourth Affiliated Hospital of Guangxi Medical University

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 (Actual)

July 1, 2022

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

June 30, 2027

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Estimate)

February 20, 2023

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124502004985979665

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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