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RecruitingNCT05735145Updated Feb 21, 2023

Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

A Phase 3 interventional study of paclitaxel combined with platinum in Uterine Cervical Neoplasms, Chemoradiotherapy and Adjuvant Chemotherapy, sponsored by Fourth Affiliated Hospital of Guangxi Medical University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Fourth Affiliated Hospital of Guangxi Medical University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 3 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Uterine Cervical Neoplasms
  • Chemoradiotherapy
  • Adjuvant Chemotherapy
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 108 is close to the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Fourth Affiliated Hospital of Guangxi Medical University is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
108 participants (estimated)

Study arms

  • 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

  • Other
    concurrent chemoradiotherapy

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

    Drug: paclitaxel combined with platinum

Interventions

  • Drugpaclitaxel combined with platinum

    Adjuvant chemotherapy with paclitaxel combined with platinum

    Also known as: Adjuvant chemotherapy with paclitaxel combined with platinum

06

What researchers measure

Primary outcomes

  1. PFS

    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 outcomes

  1. OS

    Overall survival

    Time frame: Refers to the time from randomization to death from any cause, assessed up to 1000 months

07

Study locations

1 of 1 sites recruiting
  • the Fourth Affiliated Hospital of Guangxi Medical University
    Liuzhou, Guangxi 545005, China
    • Chengjun Feng, Master · Contact · leymj@163.com · +86 18877279562
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05735145
Lead sponsor
Fourth Affiliated Hospital of Guangxi Medical University
Responsible party
Sponsor
First posted
Feb 21, 2023
Start date
Jul 1, 2022
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Feb 21, 2023

Study contacts

Huang haixin
Contact
13507726193@163.com
13507726193
Feng chengjun
Contact
leymj@163.com
18877279562
Feng chengjun
principal investigator · The The Fourth Affiliated Hospital of Guangxi Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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