Cervical Cancer
Conditions
Keywords
Cervical cancer, Preoperative treatment, Surgical approach, Hysterectomy type, Radiochemotherapy
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.
Interventions
OTHERclinical routine treatments
The cohort stratified by four factors: preoperative treatment (not received, neoadjuvant chemotherapy, preoperative radiotherapy); surgical approach (laparoscopic, abdominal, vaginal, robotic); hysterectomy types (type A, type B, type C1, type C2), primary treatment (Radical hysterectomy + pelvic lymph node dissectionp; radiochemotherapy)
Sponsors
Southern Medical University, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or other histological types carcinoma of the uterine cervix. 2. Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), FIGO 2018 stage IA2 to IIA2. 3. Underwent radical hysterectomy or radiochemotherapy. 4. ECOG Performance Status of 0 or 1.
Exclusion criteria
1. Life expectancy is less than 6 months 2. No prior malignancy 3. ECOG Performance Status of 2 to 5.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Patterns of recurrence | 60 months from primary treatment | date and localization of 1st recurrence as confirmed histologically |
| Intra-operative, peri-operative, post-operative and long term treatment related morbidity | 60 months from primary treatment | Complications of all the patients |
| The morbidity of sexual dysfunction | 60 months from primary treatment | Female Sexual Function Index (FSFI) |
| Costs of treatment | 60 months from primary treatment | — |
Countries
China
Contacts
Primary ContactChen Chunlin, PhD
Outcome results
None listed