Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05735145
Other study ID # 124502004985979665
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03225443 - Observation and Evaluation of Short-term Curative Effect of Local Advanced Cervical Cancer Treated With Particle Radiotherapy Versus Neoadjuvant Chemotherapy N/A
Recruiting NCT01373723 - Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer N/A
Completed NCT02808832 - An HPV Vaccine Provider Intervention in Safety Net Clinics N/A
Terminated NCT01234480 - Intended Use Study of the BD SurePath Plus™ Pap
Terminated NCT01194609 - A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer Phase 1/Phase 2
Completed NCT01014026 - Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention Phase 3
Terminated NCT01075412 - FLT PET Imaging for Cervical Cancer Phase 2
Completed NCT02865889 - Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications N/A
Completed NCT00377845 - Cervix Cytological Screening - Comparison of Tampon Self-Test and the Routine Smear. Phase 0
Recruiting NCT05531981 - Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer
Recruiting NCT05393440 - First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer Phase 1
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Completed NCT02866006 - Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer Phase 1/Phase 2
Completed NCT03270995 - Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study N/A
Completed NCT02320578 - 2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial N/A
Terminated NCT02900248 - CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice
Not yet recruiting NCT05065853 - Urinary and Vaginal HPV Testing in Cervical Cancer Screening
Completed NCT01231945 - Low-Cost Molecular Cervical Cancer Screening Study N/A
Completed NCT01717391 - [F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers Phase 2
Active, not recruiting NCT04947605 - Epidemiological Landscape of Cervical Cancer in Latin America