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

Primary Purpose

Cervical Cancers

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
radiation
weekly cisplatin
tri-weekly cisplatin
Sponsored by
Korea Cancer Center Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancers focused on measuring Cervical Neoplasm, chemoradiation, compliance, toxicity

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Korea Institute of Radiological & Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

weekly cisplatin

tri-weekly cisplatin

Arm Description

Weekly cisplatin 40mg/m2 during radiation therapy

cisplatin 75mg/m2 three cycles, every 3 weeks

Outcomes

Primary Outcome Measures

compliance
Percentage of completed cycles of scheduled chemotherapy in each arm Percentage of grade III and IV toxicity Delayed radiation time due to toxicity

Secondary Outcome Measures

survival
5 year progression free survival 5 year survival rate

Full Information

First Posted
March 29, 2010
Last Updated
May 7, 2014
Sponsor
Korea Cancer Center Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01097252
Brief Title
Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer
Official Title
Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea Cancer Center Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancers
Keywords
Cervical Neoplasm, chemoradiation, compliance, toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
weekly cisplatin
Arm Type
Active Comparator
Arm Description
Weekly cisplatin 40mg/m2 during radiation therapy
Arm Title
tri-weekly cisplatin
Arm Type
Experimental
Arm Description
cisplatin 75mg/m2 three cycles, every 3 weeks
Intervention Type
Radiation
Intervention Name(s)
radiation
Intervention Description
radiation with cisplatin 40mg/m2, 6 cycles, every week
Intervention Type
Drug
Intervention Name(s)
weekly cisplatin
Other Intervention Name(s)
Cisplatin
Intervention Description
weekly cisplatin 40mg/m2, 6 cycles
Intervention Type
Drug
Intervention Name(s)
tri-weekly cisplatin
Other Intervention Name(s)
Cisplatin
Intervention Description
cisplatin 75mg/m2, 3cycles, every 3 weeks
Primary Outcome Measure Information:
Title
compliance
Description
Percentage of completed cycles of scheduled chemotherapy in each arm Percentage of grade III and IV toxicity Delayed radiation time due to toxicity
Time Frame
3 month
Secondary Outcome Measure Information:
Title
survival
Description
5 year progression free survival 5 year survival rate
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Young Ryu, MD
Organizational Affiliation
Korea Institute of Radiological & Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea Institute of Radiological & Medical Sciences
City
Seoul
ZIP/Postal Code
139-706
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21840137
Citation
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.
Results Reference
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Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer

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