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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: Stereotactic radiation Arm 1; Radiation: Stereotactic radiation Arm 2; Radiation: Stereotactic radiation Arm 3; Radiation: Stereotactic radiation Arm 4

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Memorial Hospital of Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

PATIENT ELIGIBILITY Conditions for Patient Eligibility (Inclusion)

• Pathologically or cytologically confirmed NSCLC
• Stage III NSCLC according to the AJCC 7th edition staging criteria. Stage II (T1-3N1) patient that are deemed medically inoperable are also eligible.
• Concurrent chemoradiation to a radiation dose of 50.4 Gy.

• residual tumor volume after concurrent chemoradiation that is appropriate for SBRT:

  • Primary tumor <120cc (approximately 6cm diameter).
  • Mediastinal/Hilar disease: 1-2 involved regions <60cc (approximately 5cmx3cmx3cm)
• Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL.
• Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x ULN.
• ECOG performance status 0 to 2
• Minimum life expectancy of 12 weeks.
• Age older than 18 years.
• Voluntary, signed written informed consent.
• Women of childbearing potential must have a negative pregnancy test
• Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter.

Conditions for Patient Ineligibility (Exclusion)

• Disease progression during or after standard chemoradiation to 50.4 Gy
• Prior thoracic radiation other than the pre-operative radiation not greater than 50.4
• Metastatic disease
• Uncontrolled severe, intercurrent illness.
• Women who are breast-feeding.
• No chemotherapy within 2 weeks from the first SBRT treatment.
• Concurrent anticancer therapy.
• Prior complete resection of all NSCLC.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic radiation Arm 1; Dose Levels/total Dose 1 16 Gy	Radiation: Stereotactic radiation Arm 1; Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy
Experimental: Stereotactic radiation Arm 2; 2 20 Gy	Radiation: Stereotactic radiation Arm 2; Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
Experimental: Stereotactic radiation Arm 3; 3 24 Gy	Radiation: Stereotactic radiation Arm 3; Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
Experimental: Stereotactic radiation Arm 4; 4 28 Gy	Radiation: Stereotactic radiation Arm 4; Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early and Intermediate Toxicity for Dose Limiting Toxicity	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.	3 months

Collaborators and Investigators

• Sponsor: Dr Thomas DiPetrillo
• Collaborators: Memorial Hospital of Rhode Island
• Investigators: Study Chair: Howard Safran, MD, BrUOG Study Chair

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): May 16, 2017

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (Estimate): August 3, 2012

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: BrUOG 259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO