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Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

Primary Purpose

Uterine Cervical Neoplasms, Chemoradiotherapy, Adjuvant Chemotherapy

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
paclitaxel combined with platinum
Sponsored by
Fourth Affiliated Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • the Fourth Affiliated Hospital of Guangxi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

concurrent chemoradiotherapy combined with adjuvant chemotherapy

concurrent chemoradiotherapy

Arm Description

Adjuvant chemotherapy in patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy

Observation of patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy

Outcomes

Primary Outcome Measures

PFS
progression-free survival

Secondary Outcome Measures

OS
Overall survival

Full Information

First Posted
June 24, 2022
Last Updated
February 16, 2023
Sponsor
Fourth Affiliated Hospital of Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05735145
Brief Title
Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer
Official Title
A Prospective Randomized Controlled Trial for Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy in the Treatment of Advanced Cervical Cancer at 2018 FIGO Staging
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fourth Affiliated Hospital of Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms, Chemoradiotherapy, Adjuvant Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
concurrent chemoradiotherapy combined with adjuvant chemotherapy
Arm Type
Experimental
Arm Description
Adjuvant chemotherapy in patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy
Arm Title
concurrent chemoradiotherapy
Arm Type
Other
Arm Description
Observation of patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
paclitaxel combined with platinum
Other Intervention Name(s)
Adjuvant chemotherapy with paclitaxel combined with platinum
Intervention Description
Adjuvant chemotherapy with paclitaxel combined with platinum
Primary Outcome Measure Information:
Title
PFS
Description
progression-free survival
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
Secondary Outcome Measure Information:
Title
OS
Description
Overall survival
Time Frame
Refers to the time from randomization to death from any cause, assessed up to 1000 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
femal
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huang haixin
Phone
13507726193
Email
13507726193@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Feng chengjun
Phone
18877279562
Email
leymj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng chengjun
Organizational Affiliation
The The Fourth Affiliated Hospital of Guangxi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Fourth Affiliated Hospital of Guangxi Medical University
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengjun Feng, Master
Phone
+86 18877279562
Email
leymj@163.com

12. IPD Sharing Statement

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Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

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