NCT04917224

Brief Summary

The proposed study expands on the principles of SBRT (Stereotactic Body Radiation Therapy) and SABR (Stereotactic Ablative Radiotherapy) for centrally located NSCLC (Non-Small Cell Lung Cancer) to further optimize outcomes in this patient population with utilization of the adaptive workflow to maintain tumor control rates but decrease the incidence and grade of treatment-related toxicities.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
78mo left

Started May 2022

Longer than P75 for not_applicable lung-cancer

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
May 2022Oct 2032

First Submitted

Initial submission to the registry

May 11, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

May 2, 2022

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2032

Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

9.4 years

First QC Date

May 11, 2021

Last Update Submit

September 25, 2023

Conditions

Lung CancerLung Tumor

Outcome Measures

Primary Outcomes (2)

  • Treatment completion

    Number of patients who completed treatment within +/- 5 days of intended treatment.

    Plus or minus 5 days of treatment

  • Number of patients experiencing adverse events

    No greater than 15 percent of patients experience a 12-month ≥ grade 3 toxicity and ≤1 grade 5 toxicity possibly, probably, or definitely related to treatment.

    12-month of treatment

Secondary Outcomes (6)

  • Primary Tumor Control Rate

    1 year of treatment

  • Progression-free survival (PFS)

    1 year of treatment

  • Overall survival (OS)

    1 year of treatment

  • Functional Assessment of Cancer Therapy - Lung (FACT-L)

    Baseline

  • EQ-5D-5L

    3 and 12-month follow-up

  • +1 more secondary outcomes

Study Arms (2)

Cohort A: Central lung tumors

EXPERIMENTAL

Gross tumor volume (GTV) less than or equal to 1 cm from a lobar bronchus

Radiation: Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)

Cohort B: Ultra-central lung tumors

EXPERIMENTAL

Gross tumor volume (GTV) less than or equal to 1 cm from the mainstem bronchus, trachea, or esophagus

Radiation: Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)

Interventions

Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)RADIATION

Cohort A will include 30 patients with central tumors; the dose regimen prescribed is 50 Gy (Gray) in 5 fractions with a 40 hour inter-fraction interval.

Cohort A: Central lung tumors
Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)RADIATION

Cohort B will include 30 patients with ultra-central tumors; the dose regimen prescribed is 60 Gy (Gray) in 8 fractions on consecutive days.

Cohort B: Ultra-central lung tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years of age
  • Clinical diagnosis of NSCLC
  • Stage T1-2b (≤ 5 cm)

You may not qualify if:

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (i.e., carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 1 year is permitted;
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Prior chemotherapy for the study cancer
  • Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression
  • Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rosenberg SA, Mak R, Kotecha R, Loo BW Jr, Senan S. The Nordic-HILUS Trial: Ultracentral Lung Stereotactic Ablative Radiotherapy and a Narrow Therapeutic Window. J Thorac Oncol. 2021 Oct;16(10):e79-e80. doi: 10.1016/j.jtho.2021.06.030. No abstract available.

    PMID: 34561039DERIVED

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rupesh Kotecha, MD

    Miami Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2021

First Posted

June 8, 2021

Study Start

May 2, 2022

Primary Completion (Estimated)

October 1, 2031

Study Completion (Estimated)

October 1, 2032

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share