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

NCT03321747 | Terminated Phase 1 DMC FDA Device

• 1 other identifier: IUSCC-0624
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Local control during Phase 2

  2 years

• Overall survival

  2 years

Study Arms (5)

Phase 1/Dose Level 1

EXPERIMENTAL

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

Radiation: Stereotactic Ablative Body Radiation (SABR)

Phase 1/Dose Level 2

EXPERIMENTAL

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

Radiation: Stereotactic Ablative Body Radiation (SABR)

Phase 1/Dose Level 3

EXPERIMENTAL

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

Radiation: Stereotactic Ablative Body Radiation (SABR)

Phase 1/Dose Level 4

EXPERIMENTAL

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

Radiation: Stereotactic Ablative Body Radiation (SABR)

Phase 2

EXPERIMENTAL

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)

Interventions

Stereotactic Ablative Body Radiation (SABR) RADIATION

Treatments shall not be delivered more frequently than every other day.

Phase 1/Dose Level 1; Phase 1/Dose Level 2; Phase 1/Dose Level 3; Phase 1/Dose Level 4; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 at time of consent.
• Ability to provide written informed consent and HIPAA authorization.
• Pathological diagnosis of squamous cell carcinoma of the lung.
• Staging PET/CT (invasive mediastinal staging strongly encouraged but not required).
• Tumors \< 7cm
• Any location eligible for SBRT (including, but not limited to, peripheral, chest wall abutting and central tumors)
• N0 M0 disease
• Plan to undergo four or five fraction SABR
• 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)

You may not qualify if:

• Previous radiation therapy to the lung per investigator discretion.
• Inability to comply with treatment per investigator discretion.
• Inability to follow standard of care follow up recommendations per investigator discretion.
• KPS\<40

Sponsors & Collaborators

• Indiana University: lead
• Indiana University School of Medicine: collaborator

Study Sites (3)

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tim Lautenschlaeger, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 26, 2017
• Study Start: October 20, 2017
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)