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Completed

NCT Number: NCT00191100

Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix

The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy without adjuvant therapy.

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Key information

Conditions

Cancer of Cervix Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

Other names: LY188011, Gemzar

Cisplatin

Drug

Brachytherapy

Radiation

Brachytherapy, 30-35 Gy over 1 week

Pelvic Radiation

Radiation

Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks

Primary outcomes

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

    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

    Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted "Measure Type", so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented.

Secondary outcomes

  1. Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points

    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

    Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented.

  2. Local Failure Rate

    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

    Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b).

  3. Tumor Response

    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

    Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial response.

  4. Number of Participants Who Died From Any Cause at Various Time Points

    Time frame: baseline to date of death from any cause (includes 60 month follow-up period)

    Original outcome was Overall Survival, which was defined as time from baseline to death from any cause.

  5. Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points

    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

    Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Aug 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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