Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

Phase 3

Recruiting

• Conditions: Chemoradiotherapy; Uterine Cervical Neoplasms; Adjuvant Chemotherapy
• Interventions: Drug: paclitaxel combined with platinum

• Registration Number: NCT05735145
• Lead Sponsor: Fourth Affiliated Hospital of Guangxi Medical University

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.

Study Timeline

• Study First Submitted: 2022-06-24
• Study Start: 2022-07-01
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Primary Completion: 2025-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
concurrent chemoradiotherapy	paclitaxel combined with platinum	Observation of patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy
concurrent chemoradiotherapy combined with adjuvant chemotherapy	paclitaxel combined with platinum	Adjuvant chemotherapy in patients with locally advanced cervical cancer who achieved CR after concurrent chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
PFS	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 Outcome Measures

Name	Time	Method
OS	Refers to the time from randomization to death from any cause, assessed up to 1000 months	Overall survival

Trial Locations

Locations (1)

the Fourth Affiliated Hospital of Guangxi Medical University; 🇨🇳 Liuzhou, Guangxi, China