Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer
Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer
1 other identifier
interventional
104
1 country
1
Brief Summary
Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally advanced cervical cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2002
Longer than P75 for phase_3
1 active site
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
Study Start
First participant enrolled
January 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 29, 2010
CompletedFirst Posted
Study publicly available on registry
April 1, 2010
CompletedMay 9, 2014
May 1, 2014
2.9 years
March 29, 2010
May 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
compliance
1. Percentage of completed cycles of scheduled chemotherapy in each arm 2. Percentage of grade III and IV toxicity 3. Delayed radiation time due to toxicity
3 month
Secondary Outcomes (1)
survival
5 years
Study Arms (2)
weekly cisplatin
ACTIVE COMPARATORWeekly cisplatin 40mg/m2 during radiation therapy
tri-weekly cisplatin
EXPERIMENTALcisplatin 75mg/m2 three cycles, every 3 weeks
Interventions
radiation with cisplatin 40mg/m2, 6 cycles, every week
cisplatin 75mg/m2, 3cycles, every 3 weeks
Eligibility Criteria
You may qualify if:
- Histologically proven cervical cancer
- Squamous, Adenosquamous, Adeno carcinoma cell type
- International Federation of Gynecologic Oncology (FIGO) stage IIB - IVA
- Gynecologic Oncology Group (GOG) performance status 0 - 2
You may not qualify if:
- Previous history of chemotherapy or radiation
- History of other cancer
- Hypersensitivity to platinum agents
- Pregnancy
- Serious medical disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea Institute of Radiological & Medical Sciences
Seoul, 139-706, South Korea
Related Publications (1)
Ryu SY, Lee WM, Kim K, Park SI, Kim BJ, Kim MH, Choi SC, Cho CK, Nam BH, Lee ED. Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e577-81. doi: 10.1016/j.ijrobp.2011.05.002. Epub 2011 Aug 11.
PMID: 21840137RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang-Young Ryu, MD
Korea Institute of Radiological & Medical Sciences
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
- Chair of Cerivcal/Ovarian Cancer Center
Study Record Dates
First Submitted
March 29, 2010
First Posted
April 1, 2010
Study Start
January 1, 2002
Primary Completion
December 1, 2004
Study Completion
December 1, 2009
Last Updated
May 9, 2014
Record last verified: 2014-05