Trial record 8 of 1922 for:    Cervical Cancer: Clinical Trials

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00842660
First received: February 8, 2009
Last updated: January 3, 2010
Last verified: February 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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, ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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
Other Name: GEMCITABINE

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

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842660

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

Additional Information:
No publications provided

Responsible Party: Department of Obstetrics & Gynecology, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00842660     History of Changes
Other Study ID Numbers: 97-1165A3
Study First Received: February 8, 2009
Last Updated: January 3, 2010
Health Authority: Taiwan: Department of Health

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

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
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 26, 2014