CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Proton Radiotherapyradiation
Likely dose
Not stated in 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/NCT00495040
NCT00495040Phase 2Completed
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Phase II Escalated/Accelerated Proton Radiotherapy for Inoperable Stage I (T1-T2, N0, M0) and Selected Stage II (T3N0M0) Non-Small Cell Lung Cancer (NSCLC)

M.D. Anderson Cancer Center·interventional·Posted Jul 2, 2007·Updated Jan 14, 2019

In Brief

A Phase 2 clinical trial evaluating Proton Radiotherapy for Lung Cancer. Completed, enrolled 38 participants across 2 sites.

Detailed Summary

The goal of this clinical research study is to learn if escalated/accelerated proton radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side effects. The safety of this treatment will also be studied. Objectives: To assess the therapeutic efficacy and toxicities of proton radiotherapy with escalated/accelerated dose for patients with medically inoperable stage I (T1-2, N0,M0) NSCLC. Primary goals: 1. Improve 2 years progression free survival at the primary site, and 2. reduce acute and chronic toxicity Secondary goals: 1. Improve disease specific survival at 2 years. 2. Study the potential of pre- and post treatment PET/CT in predicting clinical outcome. 3. Study the role of biomarkers in predicting therapeutic response and toxicities.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Massachusetts General Hospital

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2, 2007
Enrollment StartMay 4, 2006
Primary CompletionJun 14, 2017
TodayJul 2, 2026
Enrollment to primary: 11.1 yearsPosted 19 years ago

Interventions

Proton Radiotherapyradiation

87.5 CGE with 2.5 Gy/fraction for 35 treatments