Clinical trial NCT03321747: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lung Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University School of Medicine
First posted: 2017-10-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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: 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.

Eligibility 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

Primary outcomes:
measure: Rate of dose limiting toxicities (DLTs) in each cohort during Phase 1
timeFrame: 30 days
Secondary outcomes:
measure: Local control during Phase 2
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Tim Lautenschlaeger, MD
role: PRINCIPAL_INVESTIGATOR
References: