A Trial Comparing Observation With Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer
Observation Versus Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer: A Phase 3 Prospective Multi-institutional Randomised Controlled Trial
1 other identifier
interventional
540
1 country
8
Brief Summary
Cervical cancer of early stage is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events of radical resection. The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, for incidence of adverse events and local recurrence rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2017
Longer than P75 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 6, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedJuly 14, 2017
July 1, 2017
7.8 years
March 1, 2017
July 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
5-year local-recurrence-free survival (5y-LRFS)
Percentage of patients in a treatment group who are alive without local recurrence for a 5-year period of follow-up after the date of radiotherapy completion
5 years after the date of radiotherapy completion
Secondary Outcomes (2)
Incidence of grade 3/4 adverse event
Once a week during therapy, up to 5 years after the date of radiotherapy completion
5-year overall survival (5y-OS)
5 years after the date of radiotherapy completion
Study Arms (2)
The control group (Group A)
ACTIVE COMPARATORIn Group A, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method A. The regimen of chemotherapy is cisplatin 30mg/m2 every week.
The experiment group (Group B)
EXPERIMENTALIn Group B, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method B. The regimen of chemotherapy is cisplatin 30mg/m2 every week.
Interventions
The gross tumor volume (GTV) is the residual lesion after radical resection and given a dose of 60Gy. The clinical target volume (CTV) is delineated according to the lymph drainage pathway and included all the lymphocyst. The CTV is given a dose of 45Gy.
The regimen of chemotherapy is cisplatin 30mg/m2 every week.
The gross tumor volume (GTV) is the residual lesion after radical resection and given a dose of 60Gy. The clinical target volume (CTV) is delineated according to the lymph drainage pathway and given a dose of 45Gy.
Eligibility Criteria
You may qualify if:
- Patients with pathological diagnosed cervical cancer and treated with radical resection
- Stage I-II diseases (FIGO system ver. 2014)
- Karnofsky Performance Scores ≥ 80 and expected survival ≥ 3 months
- Pelvic MRI or CT indicate existence of lymphocyst
- Need of adjuvant radiotherapy according to NCCN guidelines ver. 2016v2 (SEDLIS criteria)
You may not qualify if:
- Patients with distant metastasis before or during radiotherapy
- Severe dysfunction of heart, lung, liver, kidney or hematopoietic system
- Severe neurological, mental or endocrine diseases
- History of other malignancies
- Prior chemotherapy, radiotherapy or application of monoclonal antibodies
- Patients participated in clinical trials of other drugs within last 3 months
- Pregnant or lactating women
- Those who are considered by the researchers unsuitable to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Sun Yat-sen University Affiliated Foshan Hospital
Foshan, Guangdong, 528000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The First affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Hospital of of Guangdong Armed Police Corps
Guangzhou, Guangdong, 510507, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang, 830000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei-jun Ye, M.D
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 1, 2017
First Posted
March 6, 2017
Study Start
June 1, 2017
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
July 14, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share