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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01656460
Recruitment Status : Completed
First Posted : August 3, 2012
Results First Posted : July 24, 2015
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
Dr Thomas DiPetrillo, Brown University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Radiation: Stereotactic radiation Arm 1 Radiation: Stereotactic radiation Arm 2 Radiation: Stereotactic radiation Arm 3 Radiation: Stereotactic radiation Arm 4 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
Study Start Date : April 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : May 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Early and Intermediate Toxicity for Dose Limiting Toxicity [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656460


Locations
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United States, Rhode Island
memorial Hospital of Rhode island
Pawtucket, Rhode Island, United States, 02860
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Dr Thomas DiPetrillo
Memorial Hospital of Rhode Island
Investigators
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Study Chair: Howard Safran, MD BrUOG Study Chair
More Information
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Responsible Party: Dr Thomas DiPetrillo, Prinicipal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01656460    
Other Study ID Numbers: BrUOG 259
First Posted: August 3, 2012    Key Record Dates
Results First Posted: July 24, 2015
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr Thomas DiPetrillo, Brown University:
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases