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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014