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

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ClinicalTrials.gov Identifier: NCT01097252
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Cervical Cancers Radiation: radiation Drug: weekly cisplatin Drug: tri-weekly cisplatin Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer
Study Start Date : January 2002
Primary Completion Date : December 2004
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
Drug Information available for: Cisplatin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097252


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

Publications:
Responsible Party: Sang-Young Ryu, Chair of Cerivcal/Ovarian Cancer Center, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier: NCT01097252     History of Changes
Other Study ID Numbers: KCCH GY 1005
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents