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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00842660
Recruitment Status : Unknown
Verified February 2009 by Chang Gung Memorial Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : February 12, 2009
Last Update Posted : January 5, 2010
Eli Lilly and Company
Information provided by:
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Gemzar (gemcitabine) Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
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
Study Start Date : February 2009
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Gemzar,survival Drug: Gemzar (gemcitabine)
Gemzar(gemcitabine) Hcl has 2'deoxy-2,2'-difluorouridine monohydrochloride

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
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.

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 identifier (NCT number): NCT00842660

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Chong Jong Wang,
Kaohsiung, Taiwan, M.D
Chien-Sheng Tsai
Keelung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Eli Lilly and Company
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Principal Investigator: Chun Chieh Wang, MD Chang Gung Memorial Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital Identifier: NCT00842660    
Other Study ID Numbers: 97-1165A3
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: January 5, 2010
Last Verified: February 2009
Keywords provided by Chang Gung Memorial Hospital:
Cervical cancer
concurrent chemoradiotherapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs