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Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

NCT00449657 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-03-14

No results posted yet for this study

Summary

This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Taxol (paclitaxel)

paclitaxel 15mg/m2 Q am on Mon/Wed/Fri

PROCEDURE

Radiotherapy

Off cord thoracic radiotherapy 200cGy (total dose 1000cGy). Mon/Wed/Fri: radiotherapy is delivered at least 6 hrs after chemotherapy. Tue/Thurs: radiotherapy is delivered 24 hrs or less from the paclitaxel dose the day before. Off-cord and off-esophagus concomitant boost radiotherapy 100 cGy (total dose 500 cGy)Mon/Wed/Fri of week 5

DRUG

Carboplatin

Carboplatin AUC 5mg/min/ml, prior to Gemcitabine on Wed of weeks 8 \& 9

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 at a fixed dose rate of 10mg/m2/min on Wed during week 8 \& 9

Sponsors & Collaborators

  • Leo W. Jenkins Cancer Center

    lead OTHER

Principal Investigators

  • Paul Walker, MD · Brody School of Medicine at East Carolina University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2017-08-22
Completion
2017-08-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00449657 on ClinicalTrials.gov