Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

Uterine Cervical Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735145
• Other study ID #: 124502004985979665
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: February 2023
• Source: Fourth Affiliated Hospital of Guangxi Medical University
• Contact: Huang haixin
• Phone: 13507726193
• Email: 13507726193[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adjuvant Chemotherapy
• Chemoradiotherapy
• Uterine Cervical Neoplasms

Intervention

Drug:
• paclitaxel combined with platinum
Adjuvant chemotherapy with paclitaxel combined with platinum

Locations

Country	Name	City	State
China	the Fourth Affiliated Hospital of Guangxi Medical University	Liuzhou	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Affiliated Hospital of Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	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	OS	Overall survival	Refers to the time from randomization to death from any cause, assessed up to 1000 months