A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)
NCT03468010 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 432
Last updated 2018-03-26
Summary
Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events and local recurrence rate.
Conditions
- Cervical Cancer
- Adjuvant Chemotherapy
- Radiation
- Lymph Node Metastases
Interventions
- RADIATION
-
chemoradiation
radiation with concurrent ciplatin
- DRUG
-
Paclitaxel, Cisplatin
The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel, Cisplatin once 3 weeks.
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Wei-jun Ye, M.D · Sun Yat-sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-01
- Primary Completion
- 2025-03-01
- Completion
- 2025-03-01
Countries
- China
Study Locations
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