A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
NCT01755897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 337
Last updated 2023-05-09
Summary
We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors.
Conditions
- Uterine Cervical Neoplasms
- Cervical Cancer
- Uterine Cervical Cancer
Interventions
- PROCEDURE
-
radical hysterectomy + pelvic lymph node dissection
- DRUG
-
135-175 mg/m(2) intravenously (IV) on day 1
- DRUG
-
75 mg/m(2) IV on day 2 and 3
- DRUG
-
35 mg/m(2) IV once a week
- RADIATION
-
Pelvic RT
IMRT
Sponsors & Collaborators
-
Zhejiang University
collaborator OTHER -
Shandong University
collaborator OTHER -
Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Ding Ma, MD, PhD · Huazhong University of Science and Technology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2017-12-31
- Completion
- 2020-12-31
Countries
- China
Study Locations
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