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Stereotactic Body Radiation Therapy (SBRT) in Metastatic Non-small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01185639
First received: August 18, 2010
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

This protocol is a single arm phase II multi-center trial evaluating the efficacy of Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line chemotherapy. The core hypothesis tested is that SBRT after 4 cycles of first-line chemotherapy is feasible, safe, provides durable local control of treated lesions and improves time to progression compared to historical controls. Patients are eligible for enrollment if they have metastatic NSCLC with ≤5 lesions amenable to SBRT.


Condition Intervention Phase
Non-Small-Cell Lung Carcinoma
Liver Cancer
Adrenal Cancer
Radiation: stereotactic body radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Stereotactic Body Radiation Therapy (SBRT) After First-Line Chemotherapy for Metastatic NSCLC

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Estimated time of 1 to 3 years ] [ Designated as safety issue: Yes ]
    Measured by imaging every 3 months


Secondary Outcome Measures:
  • To assess physical function for this cohort of patients [ Time Frame: up to 6 months after treatment ] [ Designated as safety issue: No ]
    A battery of physical function measures


Estimated Enrollment: 45
Study Start Date: August 2010
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT for metastatic NSCLC
SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions
Radiation: stereotactic body radiation therapy
For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
Other Names:
  • Elekta Bodyframe
  • Cyberknife

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General

  • Patients with AJCC sixth edition metastatic non-small cell lung carcinoma
  • Pathologic diagnosis of stage 4 non-small cell lung cancer prior to enrollment.
  • Patients must have response or stable disease by RECIST criteria after 4 cycles of first-line chemotherapy
  • Maximum of number of lesions per patient will be 5 total. .
  • Patients with solitary brain metastases previously treated with surgery or stereotactic radiosurgery (+/- WBRT) and currently controlled at the time of study enrollment are also eligible. Patients with history of brain metastases must have an MRI showing no active brain metastases within 80 days of study enrollment. Patients with a history of brain metastases may have up to 5 extracranial sites of disease except for those with an untreated primary tumor where section 3.1.3.3 will also apply.
  • Patients with newly diagnosed stage IV NSCLC with an untreated primary must no more than 3 active extracranial metastatic lesions other than the primary site and regional lymph nodes.
  • Age ≥ 18 years old
  • Performance Status 0-2 (ECOG)
  • A signed study specific consent form is required.

Lung (only applies to patients with active lung lesions)

  • Patients cannot have more than 3 lung lesions
  • Local failure after surgical resection will be consider a metastatic lesion for purposes of protocol inclusion.
  • All lung lesions must be visible on CT imaging
  • Cumulative diameter of lung lesions must be <7cm
  • Patients may have active mediastinal disease in a single mediastinal nodal station if he/she has not received prior mediastinal RT
  • Must meet criteria regarding status of primary tumor site described in section 3.1.9.
  • Must be able to anticipate achieving SBRT dosimetry guidelines
  • Must have adequate lung function defined within 90 days of enrollment as: (1) Forced Expiratory Volume in 1 second (FEV1) >30% of predicted or >800 Ml, (2) diffusing capacity of the lung for carbon monoxide (DLCO) >30 % predicted and (3) no evidence of actively worsening respiratory status

Liver (only applies to patients with active liver lesions

  • Patients cannot have more than 3 liver lesions
  • All active liver lesions must be discrete on CT or MRI imaging
  • Combined diameter of all liver lesions must be <6cm
  • Must be able to anticipate achieving SBRT plan per dosimetry guidelines for the liver.
  • Liver function tests (AST, ALT, total bilirubin) should be within ≤ 3 times the upper limit of normal (ULN)
  • Serum Albumin must be >2.5g/dL
  • Patients cannot have active ascites.

Adrenal Gland

  • Unilateral adrenal disease
  • Must be able to anticipate achieving the SBRT plan per dosimetry guidelines.

Bone Lesions

  • Treatment of any bone lesion is permissible if it is anticipated that the dosimetry guidelines can be met.

Spine and Paraspinal lesions

  • Patients cannot have more than 3 vertebrae or paraspinal sites involved (each involved vertebral body or paraspinal site is scored as 1 site of disease)
  • Must be no clinical or radiographic evidence of spinal cord compression
  • If spinal metastases is within previously irradiated field, there must be a 6 month interval between prior radiation course and study enrollment
  • Prior spinal cord maximum dose at level of vertebral disease must be ≤50Gy

Exclusion Criteria:

  • Primary tumor progression on first-line chemotherapy
  • Patients with complete response to first-line chemotherapy with no measurable target for SBRT
  • >5 metastatic lesions or >3 metastatic lesions in patients with an untreated primary site are ineligible (ipsilateral hilar and mediastinal lymph nodes are considered part of an untreated primary site and are not counted as metastatic lesions)
  • Solitary brain metastases and an untreated node positive primary tumor, without other extracranial metastases amenable to SBRT are ineligible
  • Retreatment of previously irradiated tumor will be excluded per 3.1.9.2 above.
  • Mediastinal lymph nodes involving multiple mediastinal nodal stations or N3 disease are ineligible.
  • Pleural effusion known to be malignant or visible of chest xray.
  • Untreated brain metastases
  • Bilateral adrenal metastases
  • Metastases in other sites not considered amenable to SBRT
  • Patients with liver metastases cannot have received prior upper abdominal radiation
  • Prior radiation to spine (most commonly in treatment of primary lung cancer), cannot have received >50Gy to the spinal cord at the level of current vertebral metastases
  • Clinical or radiographic evidence of spinal cord compression are ineligible
  • Patients with serious, uncontrolled, concurrent infection(s).
  • Weight loss (>10% of body weight) in the prior 3 months.
  • Pregnant or lactating women
  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: NCT01185639

Contacts
Contact: Margaret Crowley, LPN 336-713-6627 mcrowley@wfubmc.edu

Locations
United States, North Carolina
Coastal Carolina Radiation Oncology Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Kyle Rusthoven, MD    910-251-1839      
Contact: Deborah Brasic, FNP    910-251-1839 ext 1122    dbrasic@ccradonc.com   
Principal Investigator: Kyle Rushthoven, MD         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Brian Lally, MD    336-713-3600    blally@wakehealth.edu   
Principal Investigator: Brian Lally, MD         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Brian Lally, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01185639     History of Changes
Other Study ID Numbers: CCCWFU 62110, NCI-2010-01877
Study First Received: August 18, 2010
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
lung cancer
metastatic
SBRT
Stereotactic body radiation therapy
liver
spine
adrenal
bone cancer
Spinal Column

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Liver Neoplasms
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014