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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03321747
• Other study ID #: IUSCC-0624
• Status: Terminated
• Phase: Phase 1
• Start date: October 20, 2017
• Est. completion date: July 9, 2020

Study information

• Verified date: July 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 9, 2020
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Indiana University Health Hospital	Indianapolis	Indiana
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall survival	Length of time start of treatment that patients are still alive	2 years