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Phase II Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

This study is currently recruiting participants.
Verified October 2017 by Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463423
First Posted: November 1, 2011
Last Update Posted: October 5, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
  Purpose
A research study using a method of treating lung cancer with focused radiation called Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR based on tumor-specific factors.

Condition Intervention Phase
Lung Cancer Diagnostic Test: PET Scan Diagnostic Test: CT Scan Radiation: SABR Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Evaluate local tumor control with individually optimized lung tumor Stereotactic Ablative Radiotherapy (SABR). Tumor control will be assessed by CT, PET-CT, and if appropriate, biopsy. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Change in toxicity from baseline of individually optimized lung tumor SABR [ Time Frame: 2 years ]
  • Feasibility of anatomically optimized audio-visual biofeedback (AVB)-coached breath-hold technique assisted by fast delivery using gated RapidArc with flattening free filter mode (FFF) in a subset of patients [ Time Frame: 2 years ]
  • Examine new biomarkers in lung tumor SABR patients. [ Time Frame: 2 years ]
  • Determine progression free survival in patients treated with individually optimized lung tumor SABR. [ Time Frame: 2 years ]
  • Determine metastasis free survival in patients treated with individually optimized lung tumor SABR. [ Time Frame: 2 years ]
  • Determine overall survival in patients treated with individually optimized lung tumor SABR. [ Time Frame: 2 years ]

Estimated Enrollment: 250
Study Start Date: October 2011
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SABR Diagnostic Test: PET Scan
Standard of Care
Other Name: Positron emission tomography
Diagnostic Test: CT Scan
Standard of Care
Other Name: Computed tomography
Radiation: SABR
Standard of Care
Other Name: Individualized Stereotactic Ablative Radiotherapy (iSABR)

Detailed Description:
Stereotactic ablative radiotherapy has emerged as an important and effective new treatment modality for lung tumors, but optimal dose regimens have not been fully established. Significant toxicity can be observed with the most commonly used dose regimens, implying that developing treatment regimens that optimize treatment based on tumor-specific factors could be of clinical benefit. This study will test a risk-adapted approach to SABR delivery aimed at maximizing tumor control while minimizing toxicity.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Limited primary or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases
  • Up to 4 lesions may be included, with none larger than 5 cm if there are more than one, or up to 7 cm if there is a single tumor
  • Both peripheral and central tumors are accepted for this trial.
  • Age > 18 years old
  • Both men and women and members of all races and ethnic groups are eligible for this trial.
  • Note: Patients may be enrolled more than once (e.g. for a new tumor)

Exclusion Criteria:

  • Evidence of uncontrolled extrathoracic metastases
  • Contraindication to receiving radiotherapy.
  • Contraindication to receiving radiotherapy
  • Age < 18 years old. Children are excluded because lung malignancies rarely occur in this age group. Furthermore, treatment requires a great deal of patient cooperation including the ability to lie still for several hours in an isolated room.
  • Pregnant and breastfeeding women are excluded; as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study. Male subjects must also agree to use effective contraception for the same period as above. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  Contacts and Locations
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): NCT01463423


Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Rachel Freiberg    650-725-0438    rachelf@stanford.edu   
Contact: Stanford Cancer Clinical Trials Office    650-498-7061    ccto-office@stanford.edu   
United States, Washington
Swedish Cancer Institute Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Maggie Klee       Maggie.Klee@swedish.org   
Canada, Ontario
Princess Margaret Cancer Center Not yet recruiting
Toronto, Ontario, Canada, ON M5G 2M9
Contact: Debbie Tsuju       Debbie.Tsuji@rmp.uhn.on.ca   
Japan
Hokkaido University Hospital Recruiting
Sapporo, Hokkaido, Japan
Contact: Yuki Sasaki    81-11-706-7977    sasaki-y@med.hokudai.ac.jp   
Principal Investigator: Hiroki Shirato         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Maximilian Diehn, MD, PhD Stanford University
Principal Investigator: Bill Loo, MD, PhD Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01463423     History of Changes
Other Study ID Numbers: LUN0048
SU-10202011-8537 ( Other Identifier: Stanford University )
IRB-22476 ( Other Identifier: Stanford University IRB Approval Number )
First Submitted: October 25, 2011
First Posted: November 1, 2011
Last Update Posted: October 5, 2017
Last Verified: October 2017