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

Phase 3CompletedNCT00191100

Eli Lilly and Company515 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

515

Conditions

Cancer of Cervix

Interventions

GemcitabineDRUG

CisplatinDRUG

BrachytherapyRADIATION

Brachytherapy, 30-35 Gy over 1 week

Pelvic radiationRADIATION

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (7)

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

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

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

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.

Local Failure Rate

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).

Tumor Response

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

Data from ClinicalTrials.gov

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