None listed
Conditions
Interventions
Gemcitabine plus cisplatin Type of group
Gemcitabina mas cisplatino con radioterapia
concurrente, seguidos de gemcitabina y cisplatino.
Group name:Control Type of group
The comparator control arm, chemoradiation based on cisplatin, is appropriate to achieve the objectives of the study.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:• Complete response (CR): Disappearance of any known disease, determined by two observations made with no less than 4 weeks apart. • Partial response (PR): A decrease of at least 50% in the total size of the lesions that have been measured to determine the effect of the therapy, in two observations made with no less than 4 weeks apart. In addition, no new lesions or progression of any lesion may have appeared. • Stable disease (ES): A decrease of at least 50% in the total tumor size can not be established, nor can a 25% increase in the size of one or more measurable lesions be established. • Progressive disease (PD): An increase of at least 25% in the size of at least one measurable lesion or the appearance of new lesions. Measure:The primary efficacy measure of the present study is 3-year progression-free survival. Timepoints:3 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Global Survival • Time to progressive disease. • Index of local failures. • Tumor response index. • Toxicity. Measure:The secondary objectives of the study are to compare the following between the two arms Timepoints:3 year | — |
Countries
Argentina, Bosnial and Herzegovina, India, Mexico, Pakistan, Peru, Thailand
Outcome results
None listed