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Consolidation Chemotherapy/Concurrent Chemo-radiotherapy for Inoperable Stage III Non-small Cell Lung Cancer (NSCLC)

NCT01336543 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-12-18

No results posted yet for this study

Summary

This is a pilot phase II study of histology based consolidation chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) following concurrent chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of consolidation with gemcitabine.

Conditions

  • Stage III Non-small Cell Lung Cancer

Interventions

DRUG

Chemotherapy following concurrent Chemoradiotherapy

1. NSCLC (Non-Small Cell Lung Cancer) 2. PE (Cisplatin 50mg/m2 on days 1,8,29,36 Etoposide 80mg/m2 days 1-3 and 29-31) 3. Radiation 59.4 Gy with 2 cycles of PE 4. (Non-squamous histology) Pemetrexed consolidation 500mg/m2 every 21 days for 4 cycles 5. (Squamous histology) Gemcitabine consolidation 1000mg/m2 days 1,8, every 21 days for 4 cycles

Sponsors & Collaborators

  • Syed Jafri

    lead OTHER

Principal Investigators

  • Syed H. Jafri, MD · LSU Health Shreveport, Feist-Weiller Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01336543 on ClinicalTrials.gov