CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Palifermin +4 moredrug
Likely dose
Palifermin (specific dose not stated in provided text); Paclitaxel and Carboplatin (doses not specified in provided text)AI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed unresectable locally advanced NSCLC (stage IIIa or IIIb)
  • ✓Radiation field must encompass ≥30% of the esophagus
  • ✓Life expectancy ≥6 months
  • ✓Weight loss ≤10% in the 3 months before randomization
Key exclusion· 13
  • ✕Metastatic disease (M1) or stage 4 NSCLC
  • ✕Pleural or pericardial effusion >100 mL (unless proven non-malignant)
  • ✕Planned surgical tumor removal before completing chemoradiotherapy
  • ✕Esophageal shielding during radiotherapy, including posterior spinal cord shielding

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

Search/NCT00094861
NCT00094861Phase 2Completed
CompareCT.gov

A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy Followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Swedish Orphan Biovitrum·interventional·Posted Oct 27, 2004·Updated Mar 14, 2017

In Brief

A Phase 2 clinical trial evaluating Palifermin, Placebo, and 3 other interventions for Dysphagia and 2 related conditions. Completed, enrolled 100 participants.

Detailed Summary

The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysphagia, Non-Small Cell Lung Cancer, Lung Cancer
Countries--
CollaboratorsAmgen

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 27, 2004
Enrollment StartJan 1, 2005
Primary CompletionDec 1, 2007
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 21.7 years ago

Interventions

Palifermindrug

Placebodrug

Radiotherapyradiation

Paclitaxeldrug

Carboplatindrug