One Fraction Simulation-Free Treatment With CT-Guided Stereotactic Adaptive Radiotherapy for Patients With Oligometastatic and Primary Lung Tumors

Not Applicable

Recruiting

• Conditions: Lung Cancer; Oligometastatic Lung Tumor
• Interventions: Radiation: One fraction stereotactic body radiotherapy; Device: HyperSight; Device: Ethos

• Registration Number: NCT06236516
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Stereotactic body radiotherapy (SBRT) has become a standard of care for medically inoperable or high-risk operable early-stage non-small cell lung cancer (NSCLC) patients. It is also increasingly used to treat lung metastases in patients with oligometastatic disease. While SBRT is a powerful tool for the treatment of lung tumors, access to specialized treatm...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-02-01
• Study Start: 2024-02-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-08-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• One of the following diagnoses:

  • Histologically or radiographically diagnosed stage I-IIA (AJCC, 8th ed.) non-small cell lung cancer .

    • Clinical AJCC stage I defined as stage 1A1 (T1a1N0M0, T1a tumor less than or equal to 1 cm), stage 1A2 (T1bN0M0, T1b tumor between 1 and 2 cm), and stage 1A3 (T1cN0M0, T1c tumor between 2 and 3 cm).
    • Clinical AJCC stage IB defined as T2aN0M0, T2a tumor between 3 and 4 cm.
    • Clinical AJCC stage IIA defined as T2bN0M0, T2b tumor between 4 and 5 cm.

  • Oligometastatic lung tumor secondary to a primary cancer of any type/histology. Oligometastatic patients may include patients with:

    • 1-5 sites of metastatic disease with at least one lung lesion intended to be treated with SBRT
    • More than 5 sites of metastatic disease with oligo-progressive disease in the lung intended to be treated with SBRT.

• Lesions must be small and peripheral.

  • Small is defined as max tumor dimension of 5 cm or less.
  • Peripheral is defined as greater than 2 cm from the proximal bronchial tree/mediastinum.

• Tumors and anatomy amenable to one-fraction lung SBRT confirmed by meeting of one-fraction lung SBRT target and constraint metrics on a diagnostic-scan based preplan.

  • Patients who do not meet this criterion will be screen fails and triaged to the standard lung SBRT workflow and treated off trial.

• Lesions must have a maximum superior to inferior motion of 1 cm on 4D-CT imaging.

  • Patients who do not meet this criteria will be screen fails and triaged to the standard lung SBRT workflow and treated off trial.

• At least 18 years of age.

• Able to understand and willing to sign an IRB approved written informed consent.

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Exclusion Criteria

• Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by ONE STOP SBRT.
• Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of ONE STOP SBRT.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One Fraction SBRT	One fraction stereotactic body radiotherapy	Consenting and eligible patients will receive a prescription dose of 25-34 Gy in one fraction with adaptation based on daily anatomic changes as per clinical standard of care.
One Fraction SBRT	Ethos	Consenting and eligible patients will receive a prescription dose of 25-34 Gy in one fraction with adaptation based on daily anatomic changes as per clinical standard of care.
One Fraction SBRT	HyperSight	Consenting and eligible patients will receive a prescription dose of 25-34 Gy in one fraction with adaptation based on daily anatomic changes as per clinical standard of care.

Primary Outcome Measures

Name	Time	Method
Feasibility of the ONE STOP workflow	Day 1	Feasibility is defined as the successful completion of the ONE STOP workflow through treatment delivery in at least 70% of patients.; Successful completion of the workflow is defined as ONE STOP plan creation and delivery of the fraction using the study workflow in one on-table attempt.; ...

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States