Induction Gemcitabine & Carboplatin Followed by Paclitaxel & Carboplatin +XRT in NSCLC

NCT00226590 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-03-23

Study results available
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Summary

This is a single institution Phase II study for patients with unresectable Stage IIIA and IIIB non-small cell lung cancer. The treatment started with 2 cycles of gemcitabine and carboplatin followed by concurrent chemotherapy with radiation. The chemoradiation included using paclitaxel and carboplatin with daily thoracic radiation to a total dose of 74 Gy. Response rate was determined following the chemotherapy with gemcitabine and carboplatin and evaluated again after the chemoradiation. Treatment toxicities were also assessed.

Conditions

Interventions

DRUG

Gemcitabine

Induction Chemotherapy.

DRUG

Carboplatin

Induction Chemotherapy. Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.

DRUG

Paclitaxel

Weekly Carboplatin and Paclitaxel During Thoracic Radiation Therapy.

PROCEDURE

Radiation

Radiation Therapy will begin on day 57 if there has been adequate hematologic recovery from Induction Chemotherapy.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Gerold Bepler, MD, PhD · Karmanos Cancer Institute (formerly at H. Lee Moffitt Cancer Center & Research Institute)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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Entities

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 NCT00226590 on ClinicalTrials.gov