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

This study has suspended participant recruitment.
(DSMC audit results)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01463423
First received: October 25, 2011
Last updated: July 31, 2014
Last verified: July 2014
  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
Procedure: PET Scan
Procedure: CT Scan
Procedure: SABR
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in toxicity from baseline of individually optimized lung tumor SABR [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Examine new biomarkers in lung tumor SABR patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Determine progression free survival in patients treated with individually optimized lung tumor SABR. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Determine metastasis free survival in patients treated with individually optimized lung tumor SABR. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Determine overall survival in patients treated with individually optimized lung tumor SABR. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 82
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SABR Procedure: PET Scan
Standard of Care
Other Name: Positron emission tomography
Procedure: CT Scan
Standard of Care
Other Name: Computed tomography
Procedure: SABR
Standard of Care
Other Name: Individualized Stereotactic Ablative Radiotherapy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01463423

Locations
United States, California
Stanford University Cancer Institute
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Maximilian Diehn, MD, PhD Stanford University
Principal Investigator: Bill Loo, MD, PhD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01463423     History of Changes
Other Study ID Numbers: LUN0048, SU-10202011-8537, 22476
Study First Received: October 25, 2011
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014