Back to resultsRadiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Gemzar (gemcitabine)
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical cancer, concurrent chemoradiotherapy, gemcitabine
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed primary squamous cell carcinoma of the uterine cervix.
- Previously untreated disease.
- Clinical FIGO stage III-IVa or pelvic/para-aortic lymph node positive by PET examination.
- No known metastases to supraclavicular nodes or other organs outside the radiotherapy field.
- Ages eligible: 35 years - 70 years.
- Patients must have adequate bone marrow, pulmonary, liver and renal function documented before radiotherapy. WBC > 3000/mm3, platelet > 100,000/mm3, serum transaminases (GOT, GPT) < 60 IU/ml, total bilirubin < 1.5mg%, creatinine < 1.4mg% (creatinine clearance > 60 ml/min).
- Performance status 0 or 1 (see Appendix I).
- The interval between RT and randomization is not greater than 3 weeks.
- Patients must have signed informed consent to participate this study.
Exclusion Criteria:
- Age > 70 or < 35
- Medical or psychological condition that would preclude treatment.
- Previous chemotherapy or pelvic RT.
- Small cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
- Patient unreliable for treatment completion and follow-up.
Sites / Locations
- Chong Jong Wang,
- Chien-Sheng Tsai
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemzar,survival
Arm Description
Outcomes
Primary Outcome Measures
Patient survival, including overall survival and progression-free survival.
Secondary Outcome Measures
1) Acute toxicity during treatment 2) Tumor response rates 3) Sites of recurrence 4) Long-term complications and quality of life
Full Information
NCT ID
NCT00842660
First Posted
February 8, 2009
Last Updated
January 3, 2010
Sponsor
Chang Gung Memorial Hospital
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00842660
Brief Title
Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic Cervical Cancer
Official Title
Phase III Trial for Primary Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in PET/CT Defined Poor-Prognostic Cervical Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, in patients with advanced cervical cancer, half of them treated with contemporary radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.
The major aim of this project is to conduct a prospective, randomized phase III clinical trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and gemcitabine have better survival rates than those treated by radiotherapy with cisplatin alone.
Gemcitabine has been demonstrated to be a good radiosensitizer. In keeping with this, few clinical trials in early phases showed promising results when using concurrent radiotherapy with cisplatin and gemcitabine. According to these positive results, the investigators expect this trial has the potential to improve the survival in patients with advanced cervical cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.
Detailed Description
I). Study end points Primary end point: Patient survival, including overall survival and progression-free survival.
Secondary end points:
Acute toxicity during treatment
Tumor response rates
Sites of recurrence
Long-term complications and quality of life II). Design of study
An open-label, prospective randomized trial with two treatment arms:
Arm I: Patients receive CCRT with weekly cisplatin only.
Arm II: Patients receive CCRT with cisplatin plus gemcitabine. III). Study population 1) Number of subjects: A total of 172 patients (86 per treatment arm) will be accrued for this study within 4 years.
Conduct of study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical cancer, concurrent chemoradiotherapy, gemcitabine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gemzar,survival
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gemzar (gemcitabine)
Other Intervention Name(s)
GEMCITABINE
Intervention Description
Gemzar(gemcitabine) Hcl has 2'deoxy-2,2'-difluorouridine monohydrochloride
Primary Outcome Measure Information:
Title
Patient survival, including overall survival and progression-free survival.
Time Frame
2012,
Secondary Outcome Measure Information:
Title
1) Acute toxicity during treatment 2) Tumor response rates 3) Sites of recurrence 4) Long-term complications and quality of life
Time Frame
2013
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed primary squamous cell carcinoma of the uterine cervix.
Previously untreated disease.
Clinical FIGO stage III-IVa or pelvic/para-aortic lymph node positive by PET examination.
No known metastases to supraclavicular nodes or other organs outside the radiotherapy field.
Ages eligible: 35 years - 70 years.
Patients must have adequate bone marrow, pulmonary, liver and renal function documented before radiotherapy. WBC > 3000/mm3, platelet > 100,000/mm3, serum transaminases (GOT, GPT) < 60 IU/ml, total bilirubin < 1.5mg%, creatinine < 1.4mg% (creatinine clearance > 60 ml/min).
Performance status 0 or 1 (see Appendix I).
The interval between RT and randomization is not greater than 3 weeks.
Patients must have signed informed consent to participate this study.
Exclusion Criteria:
Age > 70 or < 35
Medical or psychological condition that would preclude treatment.
Previous chemotherapy or pelvic RT.
Small cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
Patient unreliable for treatment completion and follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Chieh Wang, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chong Jong Wang,
City
Kaohsiung
ZIP/Postal Code
M.D
Country
Taiwan
Facility Name
Chien-Sheng Tsai
City
Keelung
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25827291
Citation
Wang CC, Chou HH, Yang LY, Lin H, Liou WS, Tseng CW, Liu FY, Liou JD, Huang KG, Huang HJ, Huang EY, Chen CH, Chang TC, Chang CJ, Hong JH, Lai CH. A randomized trial comparing concurrent chemoradiotherapy with single-agent cisplatin versus cisplatin plus gemcitabine in patients with advanced cervical cancer: An Asian Gynecologic Oncology Group study. Gynecol Oncol. 2015 Jun;137(3):462-7. doi: 10.1016/j.ygyno.2015.03.046. Epub 2015 Mar 28.
Results Reference
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Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic Cervical Cancer
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