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Trial Title:
Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer
NCT ID:
NCT05735145
Condition:
Uterine Cervical Neoplasms
Chemoradiotherapy
Adjuvant Chemotherapy
Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
paclitaxel combined with platinum
Description:
Adjuvant chemotherapy with paclitaxel combined with platinum
Arm group label:
concurrent chemoradiotherapy
Arm group label:
concurrent chemoradiotherapy combined with adjuvant chemotherapy
Other name:
Adjuvant chemotherapy with paclitaxel combined with platinum
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
femal
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the Fourth Affiliated Hospital of Guangxi Medical University
Address:
City:
Liuzhou
Zip:
545005
Country:
China
Status:
Recruiting
Contact:
Last name:
Chengjun Feng, Master
Phone:
+86 18877279562
Email:
leymj@163.com
Start date:
July 1, 2022
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Fourth Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Source:
Fourth Affiliated Hospital of Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05735145
