Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sang-Young Ryu, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier:
NCT01097252
First received: March 29, 2010
Last updated: May 7, 2014
Last verified: May 2014

March 29, 2010
May 7, 2014
January 2002
December 2004   (final data collection date for primary outcome measure)
compliance [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  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
Same as current
Complete list of historical versions of study NCT01097252 on ClinicalTrials.gov Archive Site
survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  1. 5 year progression free survival
  2. 5 year survival rate
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Cancers
  • Radiation: radiation
    radiation with cisplatin 40mg/m2, 6 cycles, every week
  • Drug: weekly cisplatin
    weekly cisplatin 40mg/m2, 6 cycles
    Other Name: Cisplatin
  • Drug: tri-weekly cisplatin
    cisplatin 75mg/m2, 3cycles, every 3 weeks
    Other Name: Cisplatin
  • Active Comparator: weekly cisplatin
    Weekly cisplatin 40mg/m2 during radiation therapy
    Interventions:
    • Radiation: radiation
    • Drug: weekly cisplatin
  • Experimental: tri-weekly cisplatin
    cisplatin 75mg/m2 three cycles, every 3 weeks
    Interventions:
    • Radiation: radiation
    • Drug: tri-weekly cisplatin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
December 2009
December 2004   (final data collection date for primary outcome measure)

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
Female
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01097252
KCCH GY 1005
No
Sang-Young Ryu, Korea Cancer Center Hospital
Korea Cancer Center Hospital
Not Provided
Principal Investigator: Sang-Young Ryu, MD Korea Institute of Radiological & Medical Sciences
Korea Cancer Center Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP