Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Radiation: Stereotactic radiation Arm 4; Radiation: Stereotactic radiation Arm 2; Radiation: Stereotactic radiation Arm 3; Radiation: Stereotactic radiation Arm 1

• Registration Number: NCT01656460
• Lead Sponsor: Dr Thomas DiPetrillo

Brief Summary

The purpose of this study is to evaluate the efficacy and toxicity stereotactic body radiation (SBRT) as consolidation following standard chemoradiation for patients with stage III non-small cell lung cancer.

Detailed Description

This protocol will investigate the potential role of SBRT for patients with stage 3 NSCLC. Eligible patients will first have received standard 50.4 Gy chemoradiation. Patients entering the study will have the opportunity to receive SBRT as a noninvasive option as compared to surgical resection. For patients who are not surgical candidates, SBRT after 50.4 Gy chemoradiation represents a technique of radiation consolidation that may be more effective and less toxic than standard conventional fractionated radiation

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-03
• Primary Completion: 2015-03
• Results First Submitted: 2015-06-29
• Results First Submitted QC: 2015-06-29
• Results First Posted: 2015-07-24
• Study Completion: 2017-05-16
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic radiation Arm 4	Stereotactic radiation Arm 4	4 28 Gy
Stereotactic radiation Arm 2	Stereotactic radiation Arm 2	2 20 Gy
Stereotactic radiation Arm 3	Stereotactic radiation Arm 3	3 24 Gy
Stereotactic radiation Arm 1	Stereotactic radiation Arm 1	Dose Levels/total Dose 1 16 Gy

Primary Outcome Measures

Name	Time	Method
Early and Intermediate Toxicity for Dose Limiting Toxicity	3 months	Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT.; DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT.

Trial Locations

Locations (2)

memorial Hospital of Rhode island; 🇺🇸 Pawtucket, Rhode Island, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States