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

Indiana University

Status and phase: Terminated; Phase 1

Conditions: Lung Cancer

Treatments: Radiation: Stereotactic Ablative Body Radiation (SABR)

Study type: Interventional

Funder types: Other

Identifiers

NCT03321747

IUSCC-0624

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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13 participants in 5 patient groups

Phase 1/Dose Level 1

Experimental group

Description:

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

Treatment:

Radiation: Stereotactic Ablative Body Radiation (SABR)

Phase 1/Dose Level 2

Experimental group

Description:

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

Treatment:

Radiation: Stereotactic Ablative Body Radiation (SABR)

Phase 1/Dose Level 3

Experimental group

Description:

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

Treatment:

Radiation: Stereotactic Ablative Body Radiation (SABR)

Phase 1/Dose Level 4

Experimental group

Description:

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

Treatment:

Radiation: Stereotactic Ablative Body Radiation (SABR)

Phase 2

Experimental group

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.

Treatment:

Radiation: Stereotactic Ablative Body Radiation (SABR)