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NCT Number: NCT05735145

Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

the Fourth Affiliated Hospital of Guangxi Medical University

Liuzhou, Guangxi, 545005, China

Location status: Recruiting

Location contact

Chengjun Feng, Master

CONTACT

[email protected]

+86 18877279562

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel combined with platinum

Drug

Adjuvant chemotherapy with paclitaxel combined with platinum

Other names: Adjuvant chemotherapy with paclitaxel combined with platinum

Primary outcomes

  1. 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

Secondary outcomes

  1. OS

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

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Feng chengjun

CONTACT

[email protected]

18877279562

Huang haixin

CONTACT

[email protected]

13507726193

Sponsors and collaborators

Lead sponsor

Fourth Affiliated Hospital of Guangxi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Feb 21, 2023
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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