Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer
30 Years
75 Years
Female
Cervical Cancers
Trial Information
Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer
This study is to compare the compliance, toxicity, response and survival rate between
concurrent chemoradiation with weekly cisplatin 40mg/m2 and three-week cisplatin 75mg/m2 in
patients with advanced cervical cancer. Patients with primary untreated invasive squamous
cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix from stage IIB to
IVA were enrolled. Patients with histologically proven locoregionally advanced cervical
cancer will be randomized into two treatment arm; Arm I, concurrent chemoradiation with
weekly cisplatin 40mg/m2 for six times; Arm II, concurrent chemoradiation with three-week
cisplatin 75mg/m2 for three times. The compliance and toxicity during the chemoradiation is
the primary endpoint. Response rate and the overall survival will be analyzed as secondary
endpoints.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous history of chemotherapy or radiation
- History of other cancer
- Hypersensitivity to platinum agents
- Pregnancy
- Serious medical disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
compliance
Outcome Description:
Percentage of completed cycles of scheduled chemotherapy in each arm Percentage of grade III and IV toxicity Delayed radiation time due to toxicity
Outcome Time Frame:
3 month
Safety Issue:
No
Principal Investigator
Sang-Young Ryu, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Korea Institute of Radiological & Medical Sciences
Authority:
South Korea: Institutional Review Board
Study ID:
KCCH GY 1005
NCT ID:
NCT01097252
Start Date:
January 2002
Completion Date:
December 2009
Related Keywords:
- Cervical Cancers
- Cervical Neoplasm
- chemoradiation
- compliance
- toxicity
- Uterine Cervical Neoplasms
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