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

Primary Purpose

Lung Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Ablative Body Radiation (SABR)

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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)

Exclusion Criteria

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

Sites / Locations

Indiana University Health Hospital
Indiana University Health Methodist Hospital
Indiana University Melvin and Bren Simon Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Phase 1/Dose Level 1

Phase 1/Dose Level 2

Phase 1/Dose Level 3

Phase 1/Dose Level 4

Phase 2

Arm Description

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

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

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Overall survival

Length of time start of treatment that patients are still alive

Full Information

NCT ID

NCT03321747

First Posted

October 23, 2017

Last Updated

July 22, 2022

Sponsor

Indiana University

Collaborators

Indiana University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03321747

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

After completion of Phase I, it was decided not to initiate Phase II of the study.

Study Start Date

October 20, 2017 (Actual)

Primary Completion Date

July 9, 2020 (Actual)

Study Completion Date

July 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

Indiana University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. 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.

Detailed Description

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. Phase II Secondary Objectives Determine overall survival, progression free survival and patterns of failure after SABR. Determine tolerability of dose escalated SABR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1/Dose Level 1

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 1/Dose Level 2

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 1/Dose Level 3

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 1/Dose Level 4

Arm Type

Experimental

Arm Description

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

Arm Title

Phase 2

Arm Type

Experimental

Arm Description

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.

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Ablative Body Radiation (SABR)

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Local control during Phase 2

Description

Time Frame

2 years

Title

Overall survival

Description

Length of time start of treatment that patients are still alive

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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) Exclusion Criteria 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tim Lautenschlaeger, MD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University Health Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Indiana University Health Methodist Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Indiana University Melvin and Bren Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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