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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

Detailed Description

Primary Objective: Evaluate local tumor control with individually optimized lung tumor SABR. Tumor control will be assessed by CT, PET-CT, and if appropriate, biopsy. The trial will focus on three cohorts: 1) patients with limited primary NSCLCs (T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0) non-small cell lung cancer; 2) patients with a history of NSCLC who have new limited primary NSCLC lesion(s); and 3) patients with more advanced lung cancer or lung metastases from a variety of different cancers.

Secondary Objective:

- Evaluate the toxicity of individually optimized lung tumor SABR. Pulmonary, esophageal, chest wall, skin, vascular, cardiac/pericardial, and neurologic (brachial plexus/recurrent laryngeal/myelitis) toxicity will be scored by the CTCAE 4.0 criteria.

- Evaluate the 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. Feasibility will be assessed based on: i) The proportion of patients able to reproduce an anatomically-optimized breath-hold with AVB-coaching during treatment. ii) The reduction in treatment delivery time compared to gated free-breathing treatment.

- Determine progression free, metastasis free, and overall survival in patients treated with individually optimized lung tumor SABR.

- Examine new biomarkers in lung tumor SABR patients.

Interventions

  • Radiation: Individualized Stereotactic Ablative Radiotherapy (iSABR)
    • Standard of Care describing dosing here

Arms, Groups and Cohorts

  • Experimental: Limited primary NSCLCs
    • Participants with limited primary NSCLCs (T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0) non-small cell lung cancer;
  • Experimental: History of NSCLC
    • Participants with a history of NSCLC who have new limited primary NSCLC lesion(s)
  • Experimental: Advanced lung cancer
    • Participants with more advanced lung cancer or lung metastases from a variety of different cancers.

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

Inclusion Criteria

  • Limited primary NSCLCs (T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0) or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases.
  • Up to 4 lesions may be included. For a single lesion the sum of three orthogonal diameters can be no more than 20 cm. For multiple lesions, no lesion can have a sum of orthogonal diameters greater than 15 cm.
  • 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 (eg, for a new tumor)
  • 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
  • Age < 18 years old.
  • Pregnant and breastfeeding women are excluded
  • Prior radiation therapy is allowed but there should not be overlap with the prior high dose regions unless approved by the protocol directors.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maximilian Diehn, MD, PhD, Principal Investigator, Stanford University
    • Bill Loo, MD, PhD, Principal Investigator, Stanford University

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