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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic radiation Arm 1
Stereotactic radiation Arm 2
Stereotactic radiation Arm 3
Stereotactic radiation Arm 4
Sponsored by
Dr Thomas DiPetrillo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • memorial Hospital of Rhode island
  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Stereotactic radiation Arm 1

Stereotactic radiation Arm 2

Stereotactic radiation Arm 3

Stereotactic radiation Arm 4

Arm Description

Dose Levels/total Dose 1 16 Gy

2 20 Gy

3 24 Gy

4 28 Gy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2012
Last Updated
July 7, 2020
Sponsor
Dr Thomas DiPetrillo
Collaborators
Memorial Hospital of Rhode Island
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1. Study Identification

Unique Protocol Identification Number
NCT01656460
Brief Title
Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
Official Title
Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Thomas DiPetrillo
Collaborators
Memorial Hospital of Rhode Island

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic radiation Arm 1
Arm Type
Experimental
Arm Description
Dose Levels/total Dose 1 16 Gy
Arm Title
Stereotactic radiation Arm 2
Arm Type
Experimental
Arm Description
2 20 Gy
Arm Title
Stereotactic radiation Arm 3
Arm Type
Experimental
Arm Description
3 24 Gy
Arm Title
Stereotactic radiation Arm 4
Arm Type
Experimental
Arm Description
4 28 Gy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiation Arm 1
Intervention Description
Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiation Arm 2
Intervention Description
Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiation Arm 3
Intervention Description
Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiation Arm 4
Intervention Description
Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
Primary Outcome Measure Information:
Title
Early and Intermediate Toxicity for Dose Limiting Toxicity
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Safran, MD
Organizational Affiliation
BrUOG Study Chair
Official's Role
Study Chair
Facility Information:
Facility Name
memorial Hospital of Rhode island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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