Concurrent Chemoradiation With Cisplatin Every 3 Week in Advanced Cervical Cancer
NCT00916500 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71
Last updated 2014-05-01
Summary
Concurrent chemoradiation (CCRT) is the standard therapy for locally advanced cervical cancer.
However, the most effective chemotherapy regimen is controversial. Weekly cisplatin, hydroxyurea + cisplatin, 5-FU + cisplatin are tested in clinical trials.
Weekly cisplatin needs frequent hospital visits and had a poor compliance profile in korea.
Combination chemotherapy regimens had more adverse effects than weekly cisplatin without improving outcomes.
We conducted a retrospective analysis comparing weekly cisplatin with cisplatin every 3 weeks and observed favorable outcome for cisplatin every 3 weeks regimen (still not published).
Therefore, we designed a phase 2 trial evaluating the efficacy and feasibility of CCRT with cisplatin every 3 weeks.
Conditions
- CERVICAL NEOPLASMS
Interventions
- DRUG
-
CONCURRENT CHEMORADIATION (CISPLATIN)
Cisplatin IV 75mg/m2 Every 3 Week For 3 Cycles; External Pelvic Radiation 40Gy; Brachytherapy Up To 85-90 Gy To Point A
Sponsors & Collaborators
-
Korea Cancer Center Hospital
lead OTHER
Principal Investigators
-
SANG YOUNG RYU, M.D. · STAFF
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-03-31
- Primary Completion
- 2013-12-31
- Completion
- 2013-12-31
Countries
- South Korea
Study Locations
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