CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
SBRT 40.0 Gy +8 moreradiation
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/NCT00750269
NCT00750269Phase 2Completed
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Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients

Radiation Therapy Oncology Group·interventional·Posted Sep 10, 2008·Updated Jun 9, 2022

In Brief

A Phase 2 clinical trial evaluating SBRT 40.0 Gy, SBRT 42.5 Gy, and 7 other interventions for Lung Cancer. Completed, enrolled 120 participants across 58 sites in 2 countries.

Detailed Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I non-small cell lung cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI), NRG Oncology

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2008
Enrollment StartFeb 1, 2009
Primary CompletionSep 1, 2014
Study CompletionMay 20, 2022
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 17.8 years ago

Interventions

SBRT 40.0 Gyradiation

SBRT delivered in 5 fractions of 8.0 Gy/fraction over 1.5 to 2 weeks for a total of 40.0 Gy

SBRT 42.5 Gyradiation

SBRT delivered in 5 fractions of 8.5 Gy/fraction over 1.5 to 2 weeks for a total of 42.5 Gy

SBRT 45.0 Gyradiation

SBRT delivered in 5 fractions of 9.0 Gy/fraction over 1.5 to 2 weeks for a total of 45.0 Gy

SBRT 47.5 Gyradiation

SBRT delivered in 5 fractions of 9.5 Gy/fraction over 1.5 to 2 weeks for a total of 47.5 Gy

SBRT 50.0 Gyradiation

SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy

SBRT 52.5 Gyradiation

SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy

SBRT 55.0 Gyradiation

SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

SBRT 57.5 Gyradiation

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

SBRT 60.0 Gyradiation

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy