NCT00750269|CompletedPhase 1ResultsDMC

Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

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 ClinicalTrials.gov

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3 other identifiers

RTOG-0813CDR0000613524NCI-2009-01095

Study Type

interventional

Target

120

Locations

2 countries

Sites

Timeline

RegisteredSep 2008

StartedFeb 2009

CompletionMay 2022

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

120

participants targeted

Target at P75+ for phase_1 lung-cancer

Timeline

Completed

Started Feb 2009

Longer than P75 for phase_1 lung-cancer

Geographic Reach

2 countries

58 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

13.3 years study duration

First Submitted

Initial submission to the registry

September 9, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed

5 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed

2.7 years until next milestone

Results Posted

Study results publicly available

May 10, 2017

Completed

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed

Last Updated

June 9, 2022

Status Verified

May 1, 2022

Enrollment Period

5.6 years

First QC Date

September 9, 2008

Results QC Date

June 30, 2016

Last Update Submit

May 23, 2022

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

(Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0
Maximum tolerated dose (MTD) defined as dose most closely associated with a 20% probability of experiencing a toxicity \<= 1 year from start of SBRT from following dose-limiting toxicities: Gr 3-5 Cardiac: Pericardial effusion, Pericarditis, Restrictive cardiomyopathy; Gr 4-5 GI: Dysphagia, Esophagitis, Esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage; Gr 3-5 Nervous System Disorders: Brachial plexopathy, Recurrent laryngeal nerve palsy, Myelitis; Gr 3-5 Respiratory: Atelectasis (gr 4-5 only), Bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, Bronchial/pulmonary/bronchopleural/tracheal fistula, Hypoxia (provided gr 3 is worse than baseline), Bronchial/tracheal obstruction, Pleural effusion, Pneumonitis, Pulmonary fibrosis; Changes in Pulmonary Function Tests per SBRT Pulmonary Toxicity Scale, Gr 3-5: FEV1 decline, FVC decline; Any Gr 5 adverse event attributed to treatment. Dose level was determined by time-to-event continual reassessment method (TITE-CRM).
From start of SBRT to 1 year
(Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD)
Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.
From start of SBRT to 2 years.

Secondary Outcomes (7)

Progression-free Survival
From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
Overall Survival
From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
Local Progression
From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.
Nodal Progression
From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
Distant Metastases
From randomization to date of death, distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.
+2 more secondary outcomes

Study Arms (9)

Level 1: 8.0 Gy/FX

EXPERIMENTAL

SBRT 40.0 Gy

Radiation: SBRT 40.0 Gy

Level 2: 8.5 Gy/FX

EXPERIMENTAL

SBRT 42.5 Gy

Radiation: SBRT 42.5 Gy

Level 3: 9.0 Gy/FX

EXPERIMENTAL

SBRT 45.0 Gy

Radiation: SBRT 45.0 Gy

Level 4: 9.5 Gy/FX

EXPERIMENTAL

SBRT 47.5 Gy

Radiation: SBRT 47.5 Gy

Level 5: 10.0 Gy/FX

EXPERIMENTAL

SBRT 50.0 Gy

Radiation: SBRT 50.0 Gy

Level 6: 10.5 Gy/FX

EXPERIMENTAL

SBRT 52.5 Gy

Radiation: SBRT 52.5 Gy

Level 7: 11.0 Gy/FX

EXPERIMENTAL

SBRT 55.0 Gy

Radiation: SBRT 55.0 Gy

Level 8: 11.5 Gy/FX

EXPERIMENTAL

SBRT 57.5 Gy

Radiation: SBRT 57.5 Gy

Level 9: 12.0 Gy/FX

EXPERIMENTAL

SBRT 60.0 Gy

Radiation: SBRT 60.0 Gy