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Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

NCT00238615 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-05-12

Study results available
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Summary

The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.

Conditions

Interventions

DRUG

Docetaxel

20 mg/m2, 75 mg/m2 infusion

DRUG

Carboplatin

AUC of 2 and 6 infusion

PROCEDURE

Radiation therapy

NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.

PROCEDURE

Surgical resection

All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.

Sponsors & Collaborators

Principal Investigators

  • Heather A. Wakelee · Stanford 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
2003-03-31
Primary Completion
2009-09-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00238615 on ClinicalTrials.gov