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Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic Cervical Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Chang Gung Memorial Hospital.
Recruitment status was:  Enrolling by invitation
Eli Lilly and Company
Information provided by:
Chang Gung Memorial Hospital Identifier:
First received: February 8, 2009
Last updated: January 3, 2010
Last verified: February 2009

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.

Condition Intervention Phase
Cervical Cancer Drug: Gemzar (gemcitabine) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Trial for Primary Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in PET/CT Defined Poor-Prognostic Cervical Cancer Patients

Resource links provided by NLM:

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Patient survival, including overall survival and progression-free survival. [ Time Frame: 2012, ]

Secondary Outcome Measures:
  • 1) Acute toxicity during treatment 2) Tumor response rates 3) Sites of recurrence 4) Long-term complications and quality of life [ Time Frame: 2013 ]

Estimated Enrollment: 172
Study Start Date: February 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemzar,survival Drug: Gemzar (gemcitabine)
Gemzar(gemcitabine) Hcl has 2'deoxy-2,2'-difluorouridine monohydrochloride

Detailed Description:

I). Study end points Primary end point: Patient survival, including overall survival and progression-free survival.

Secondary end points:

  1. Acute toxicity during treatment
  2. Tumor response rates
  3. Sites of recurrence
  4. 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


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00842660

Chong Jong Wang,
Kaohsiung, Taiwan, M.D
Chien-Sheng Tsai
Keelung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Eli Lilly and Company
Principal Investigator: Chun Chieh Wang, MD Chang Gung Memorial Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Identifier: NCT00842660     History of Changes
Other Study ID Numbers: 97-1165A3
Study First Received: February 8, 2009
Last Updated: January 3, 2010

Keywords provided by Chang Gung Memorial Hospital:
Cervical cancer
concurrent chemoradiotherapy

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
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 19, 2017