CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 275 enrolled
Drug / intervention
Paclitaxel +3 moredrug
Likely dose
Paclitaxel 50 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00915005
NCT00915005Phase 2Completed

A Bayesian Randomized 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

M.D. Anderson Cancer Center·interventional·Posted Jun 5, 2009·Updated May 26, 2020

In Brief

A Phase 2 clinical trial evaluating Photon Therapy, Proton Therapy, and 2 other interventions for Non-Small-Cell Lung Carcinoma. Completed, enrolled 275 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 5, 2009
Enrollment StartJun 1, 2009
Primary CompletionFeb 24, 2020
TodayJul 2, 2026
Enrollment to primary: 10.7 yearsPosted 17.1 years ago

Interventions

Photon Therapyradiation

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.

Proton Therapyradiation

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.

Paclitaxeldrug

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

Carboplatindrug

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