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

This study is currently recruiting participants.
Verified April 2013 by Brown University
Sponsor:
Collaborator:
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
Dr Thomas DiPetrillo, Brown University
ClinicalTrials.gov Identifier:
NCT01656460
First received: July 24, 2012
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Lung Cancer
Radiation: stereotactic
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • early and intermediate toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 18
Study Start Date: April 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic radiation Radiation: stereotactic

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PATIENT ELIGIBILITY Conditions for Patient Eligibility

  • 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

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656460

Contacts
Contact: Kayla Rosati 401-863-3000 kayla_rosati@brown.edu

Locations
United States, Rhode Island
memorial Hospital of Rhode island Recruiting
Pawtucket, Rhode Island, United States, 02860
Contact: patti wingate    401-729-2225    patti_wingate@mhri.org   
Principal Investigator: anthony thomas, MD         
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: kayla rosati    401-863-3000    kayla_rosati@brown.edu   
Sub-Investigator: jaroslaw hepel, md         
Sub-Investigator: howard safran, md         
Principal Investigator: thomas dipetrillo, md         
Sponsors and Collaborators
Dr Thomas DiPetrillo
Memorial Hospital of Rhode Island
  More Information

No publications provided

Responsible Party: Dr Thomas DiPetrillo, Prinicipal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01656460     History of Changes
Other Study ID Numbers: BrUOG 259
Study First Received: July 24, 2012
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brown University:
Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014