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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01097252
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Sang-Young Ryu, Korea Cancer Center Hospital

Tracking Information
First Submitted Date  ICMJE March 29, 2010
First Posted Date  ICMJE April 1, 2010
Last Update Posted Date May 9, 2014
Study Start Date  ICMJE January 2002
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2010)
compliance [ Time Frame: 3 month ]
  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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2010)
survival [ Time Frame: 5 years ]
  1. 5 year progression free survival
  2. 5 year survival rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer
Official Title  ICMJE Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2012)
104
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2010)
150
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01097252
Other Study ID Numbers  ICMJE KCCH GY 1005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang-Young Ryu, Korea Cancer Center Hospital
Study Sponsor  ICMJE Korea Cancer Center Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sang-Young Ryu, MD Korea Institute of Radiological & Medical Sciences
PRS Account Korea Cancer Center Hospital
Verification Date May 2014

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