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

Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: Stereotactic Ablative Body Radiation (SABR)

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.

2. Phase II Secondary Objectives

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

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Methodist Hospital
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin and Bren Simon Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control during Phase 2	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 years
Overall survival	Length of time start of treatment that patients are still alive	2 years

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2017
• Primary Completion (ACTUAL): July 9, 2020
• Study Completion (ACTUAL): July 9, 2020

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (ACTUAL): October 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms, Squamous Cell; Lung Neoplasms; Carcinoma, Squamous Cell
• Other Study ID Numbers: IUSCC-0624

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes