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Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung

Sponsor
Indiana University (Other)
Overall Status
Terminated
CT.gov ID
NCT03321747
Collaborator
Indiana University School of Medicine (Other)
13
Enrollment
3
Locations
5
Arms
32.6
Actual Duration (Months)
4.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test whether 5 fraction stereotactic ablative body radiation (SABR) is safe and improves local control for early state squamous cell carcinoma of the lung. While three fraction SABR is effective for the treatment of early stage non small cell lung carcinoma (NSCLC) of all histologies, it is not safe for many patients. While four and five fraction SABR is safe, recently published data and our institutional data suggests that local control for early stage squamous cell carcinoma of the lung using the current four or five fraction SABR is suboptimal.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Stereotactic Ablative Body Radiation (SABR)
 Phase 1

Detailed Description

  1. Primary Objectives During Phase I study - Determine the safety and maximum tolerated radiation dose for five fraction SABR for squamous cell cancer of the lung.

During Phase II study - Determine 2 year local control of dose escalated five fraction SABR vs. institutional historical control standard dose SABR in squamous cell cancer of the lung.

  1. Phase II Secondary Objectives

  • Determine overall survival, progression free survival and patterns of failure after SABR.

  • Determine tolerability of dose escalated SABR.

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
This trial is a Phase I/II study designed to determine the maximum tolerated radiation dose and evaluate the efficacy of dose escalated SABR for early stage lung squamous cell carcinoma. *The Phase l portion of this study was completed. However; the trial will not continue into Phase II as originally planned.This trial is a Phase I/II study designed to determine the maximum tolerated radiation dose and evaluate the efficacy of dose escalated SABR for early stage lung squamous cell carcinoma. *The Phase l portion of this study was completed. However; the trial will not continue into Phase II as originally planned.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
Actual Study Start Date :
Oct 20, 2017
Actual Primary Completion Date :
Jul 9, 2020
Actual Study Completion Date :
Jul 9, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase 1/Dose Level 1

11 Gy will be given in 5 fractions for a total dose of 55 Gy

Radiation: Stereotactic Ablative Body Radiation (SABR)
Treatments shall not be delivered more frequently than every other day.
Experimental: Phase 1/Dose Level 2

12 Gy will be given in 5 fractions for a total dose of 60 Gy

Radiation: Stereotactic Ablative Body Radiation (SABR)
Treatments shall not be delivered more frequently than every other day.
Experimental: Phase 1/Dose Level 3

13 Gy will be given in 5 fractions for a total dose of 65 Gy

Radiation: Stereotactic Ablative Body Radiation (SABR)
Treatments shall not be delivered more frequently than every other day.
Experimental: Phase 1/Dose Level 4

14 Gy will be given in 5 fractions for a total dose of 70 Gy

Radiation: Stereotactic Ablative Body Radiation (SABR)
Treatments shall not be delivered more frequently than every other day.
Experimental: Phase 2

The maximum tolerated radiation dose determined during Phase 1 (i.e. 11, 12, 13, or 14 Gy) will be given in 5 fractions for a total dose of 55, 60, 65, or 70 Gy.

Radiation: Stereotactic Ablative Body Radiation (SABR)
Treatments shall not be delivered more frequently than every other day.

Outcome Measures

Primary Outcome Measures

  1. Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1 [30 days]

    Any event per CTCAE v.4 that occurs within 30 days from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol.

Secondary Outcome Measures

  1. Local control during Phase 2 [2 years]

    Failures will be classified as local failures if failing within or immediately adjacent to the PTV, unless judged by the investigator team to convincingly be a separate lesion from the treated lesion (i.e. new lesion within a planning target volume but across a fissure).

  2. Overall survival [2 years]

    Length of time start of treatment that patients are still alive

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria

  1. Age ≥ 18 at time of consent.

  2. Ability to provide written informed consent and HIPAA authorization.

  3. Pathological diagnosis of squamous cell carcinoma of the lung.

  4. Staging PET/CT (invasive mediastinal staging strongly encouraged but not required).

  5. Tumors < 7cm

  6. Any location eligible for SBRT (including, but not limited to, peripheral, chest wall abutting and central tumors)

  7. N0 M0 disease

  8. Plan to undergo four or five fraction SABR

  9. Baseline PFTs available within 6 months of treatment start or will be obtained prior to treatment start (no finding will exclude patient from enrollment in trial)

Exclusion Criteria

  1. Previous radiation therapy to the lung per investigator discretion.

  2. Inability to comply with treatment per investigator discretion.

  3. Inability to follow standard of care follow up recommendations per investigator discretion.

  4. KPS<40

Contacts and Locations

Locations

Site City State Country Postal Code
1 Indiana University Health Hospital Indianapolis Indiana United States 46202
2 Indiana University Health Methodist Hospital Indianapolis Indiana United States 46202
3 Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Indiana University
  • Indiana University School of Medicine

Investigators

  • Principal Investigator: Tim Lautenschlaeger, MD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tim Lautenschlaeger, Assistant Professor of Radiation Oncology, Indiana University
ClinicalTrials.gov Identifier:
NCT03321747
Other Study ID Numbers:
  • IUSCC-0624
First Posted:
Oct 26, 2017
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Lung Neoplasms

Study Results

No Results Posted as of Jul 26, 2022