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Phase 3 Randomized Comparison of Concurrent Gemcitabine, Cisplatin, and Radiation Followed by Adjuvant Gemcitabine and Cisplatin Versus Concurrent Cisplatin and Radiation in Cancer of the Cervix Stages IIB to IVA


Phase 3
18 Years
70 Years
Not Enrolling
Female
Cancer of Cervix

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Trial Information

Phase 3 Randomized Comparison of Concurrent Gemcitabine, Cisplatin, and Radiation Followed by Adjuvant Gemcitabine and Cisplatin Versus Concurrent Cisplatin and Radiation in Cancer of the Cervix Stages IIB to IVA


Inclusion Criteria:



- diagnosed with cancer of cervix

- tumor that can be measured

- no previous treatment with chemotherapy or radiation for this cancer

- Karnofsky Performance Status Score >=70

- able to give written consent

- willing and able to participate in the study, both during the active treatment and
the follow-up period.

Exclusion Criteria:

- impairment such as hearing loss from prior cisplatin therapy

- damage to nerves such as being unable to distinguish hot and cold to touch

- used other experimental medication in past 30 days

- lab test results are not within the limits required for this study

- pregnancy or breast-feeding or possibility of becoming pregnant during this study and
not using an approved method of birth control.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years

Outcome Time Frame:

Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Mexico: National Institute of Public Health, Health Secretariat

Study ID:

4015

NCT ID:

NCT00191100

Start Date:

May 2002

Completion Date:

April 2008

Related Keywords:

  • Cancer of Cervix
  • Uterine Cervical Neoplasms

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