CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
gemcitabine +2 moredrug
Likely dose
Cisplatin 80 mg/m² IV every 21 days × 5 cycles; gemcitabine 1250 mg/m² IV days 1 and 8 every 21 days × 3 cycles, then 300 mg/m² × 2 cycles; concurrent thoracic radiotherapy 63 Gy in 35 treatments over 7 weeks (cycles 4–5)AI-extracted
Key inclusion· 3
  • ✓Inoperable non-small cell lung cancer, Stage III
  • ✓Adequate hematological parameters
  • ✓Adequate lung function reserve
Key exclusion· 2
  • ✕Prior chemotherapy and thoracic radiation for non-small cell lung cancer
  • ✕Presence of distant metastases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00192036
NCT00192036Phase 2Completed
CompareCT.gov

Multicenter Phase II Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer

Eli Lilly and Company·interventional·Posted Sep 19, 2005·Updated Dec 9, 2010

In Brief

A Phase 2 clinical trial evaluating gemcitabine, cisplatin, and 1 other intervention for Non Small Cell Lung Cancer. Completed, enrolled 49 participants across 8 sites.

Detailed Summary

The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer
CountriesBelgium
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartAug 1, 2004
Primary CompletionJan 1, 2008
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.8 years ago

Interventions

gemcitabinedrug

1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5)

cisplatindrug

80 mg/m2, IV, every 21 days x 5 cycles

radiationradiation

63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5