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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: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

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
 Drug: Cisplatin plus radiotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Korea Cancer Center Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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
Experimental: control arm
Weekly cisplatin 40mg/m2 during radiation therapy
 Drug: Cisplatin plus radiotherapy
Pelvic radiation concommitant with weekly cisplatin 40mg/m2 for control arm; Pelvic radiation concommitant with triweekly cisplatin 75mg/m2 for experimental arm
Other Name: cisplatin
Experimental: experimental
Cisplatin 75mg/m2 every three weeks during radiation therapy
 Drug: Cisplatin plus radiotherapy
Pelvic radiation concommitant with weekly cisplatin 40mg/m2 for control arm; Pelvic radiation concommitant with triweekly cisplatin 75mg/m2 for experimental arm
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 29, 2010
Last Updated: March 27, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013