Effect of Different Treatments on the Prognosis of Early Cervical Cancer: A Multicenter, Prospective, Real-world Study
- Conditions
- Cervical Cancer
- Registration Number
- NCT04272190
- Lead Sponsor
- Southern Medical University, China
- Brief Summary
To observe the effects of different treatments on the oncological outcome and complications of early cervical cancer (2018 FIGO stage IA1 with lymphovascular space invasion and IA2-IIA2 cervical cancer). This study prospectively collecting enrolled cervical cancer patients clinical data and outcome from June 2020 to June 2025. (Classification factors: preoperative neoadjuvant treatment , surgical approach, type of hysterectomy, whether to receive radiochemotherapy) . This study is an observational study, and segmented analysis according to different treatment methods.
- Detailed Description
Objectives: To observe the effects of different treatments on the oncological outcome and complications of early cervical cancer (2018 FIGO stage IA1 with lymphovascular space invasion and IA2-IIA2 cervical cancer).
Study Design: We obtained the demographic, clinical, treatment hospital and complication data of patients with cervical cancer undergoing radical hysterectomy from 2004 to 2015 at 37 hospitals. The patients were assigned into groups. Classification factors: preoperative neoadjuvant treatment (not received, neoadjuvant chemotherapy, preoperative radiotherapy) , surgical approach (abdomincal, laparoscopic, vaginal, robotic surgery), type of hysterectomy (type B, type C1, type C2), primary treatment (radiochemotherapy or surgery).
laparoscopic and abdominal surgery groups. The differences in the survival, complication rates, quality of life, and cost were analyzed using univariate and multivariable logistic regression models.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 20000
- Histologically confirmed primary adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or other histological types carcinoma of the uterine cervix.
- Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), FIGO 2018 stage IA2 to IIA2.
- Underwent radical hysterectomy or radiochemotherapy.
- ECOG Performance Status of 0 or 1.
- Life expectancy is less than 6 months
- No prior malignancy
- ECOG Performance Status of 2 to 5.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (OS) 60 months from primary treatment Overall survival was defined as the period from initial treatment until cervical cancer related death.
disease-free survival (DFS) 60 months from primary treatment Tumor-free survival was defined as the period from initial treatment until the recurrence or the date of last follow-up.
- Secondary Outcome Measures
Name Time Method Patterns of recurrence 60 months from primary treatment date and localization of 1st recurrence as confirmed histologically
Costs of readmission 60 months from primary treatment Quality of life Questionnaires 60 months from primary treatment The European O-rganization for Reasearch and Treatment of Cance QLQ-30 Questionnaires to measure quality of life for any kind cancer patient. The Europe Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Cervical Cancer Module is a supplementary questionnaire for evaluating the quality of life of patients with cervical cancer.
The morbidity of sexual dysfunction 60 months from primary treatment Female Sexual Function Index (FSFI)
Intra-operative, peri-operative, post-operative and long term treatment related morbidity 60 months from primary treatment Complications of all the patients
Costs of treatment 60 months from primary treatment
Trial Locations
- Locations (1)
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China