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

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

Condition Intervention Phase
Cervical Cancers
Radiation: radiation
Drug: weekly cisplatin
Drug: tri-weekly cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer

Resource links provided by NLM:

Further study details as provided by Sang-Young Ryu, Korea Cancer Center Hospital:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • survival [ Time Frame: 5 years ]
    1. 5 year progression free survival
    2. 5 year survival rate

Enrollment: 104
Study Start Date: January 2002
Study Completion Date: December 2009
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: weekly cisplatin
Weekly cisplatin 40mg/m2 during radiation therapy
Radiation: radiation
radiation with cisplatin 40mg/m2, 6 cycles, every week
Drug: weekly cisplatin
weekly cisplatin 40mg/m2, 6 cycles
Other Name: Cisplatin
Experimental: tri-weekly cisplatin
cisplatin 75mg/m2 three cycles, every 3 weeks
Radiation: radiation
radiation with cisplatin 40mg/m2, 6 cycles, every week
Drug: tri-weekly cisplatin
cisplatin 75mg/m2, 3cycles, every 3 weeks
Other Name: Cisplatin

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.

Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01097252

Korea, Republic of
Korea Institute of Radiological & Medical Sciences
Seoul, Korea, Republic of, 139-706
Sponsors and Collaborators
Korea Cancer Center Hospital
Principal Investigator: Sang-Young Ryu, MD Korea Institute of Radiological & Medical Sciences
  More Information

Responsible Party: Sang-Young Ryu, Chair of Cerivcal/Ovarian Cancer Center, Korea Cancer Center Hospital Identifier: NCT01097252     History of Changes
Other Study ID Numbers: KCCH GY 1005
Study First Received: March 29, 2010
Last Updated: May 7, 2014

Keywords provided by Sang-Young Ryu, Korea Cancer Center Hospital:
Cervical Neoplasm

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents processed this record on May 25, 2017