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Trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, With Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence

NCT00915005 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2020-05-26

Study results available
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Summary

The goal of this clinical research study is to learn if, compared with regular x-ray radiation, proton radiation reduces the risk of developing, treatment-related pneumonitis (TRP) or tumor recurrence (the tumor coming back in the irradiated area after treatment) in patients with lung cancer.

Conditions

  • Non-Small-Cell Lung Carcinoma

Interventions

RADIATION

Photon Therapy

Group 1: 74 Gy 37 radiation treatments, given 5 days a week for about 7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete.

RADIATION

Proton Therapy

Group 2: 74 Gy in 2 CGE per fraction given 5 days a week for about 7 1/2 weeks. Group 3: 66 Gy with conventional fractionation given 5 days a week for about 6-7 1/2 weeks. Each daily treatment should take about 20-30 minutes to complete.

DRUG

Paclitaxel

50 mg/m2 by vein 1 time each week for 7 weeks.

DRUG

Carboplatin

AUC 2 by vein 1 time each week for 7 weeks.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Zhongxing Liao, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2020-02-24
Completion
2020-02-24
FDA Drug
Yes

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 NCT00915005 on ClinicalTrials.gov