SABR: Phase II Image Guided Stereotactic Ablative Radiotherapy for Non-Small Cell Lung Cancer

• Sponsor: West Virginia University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02262000
• Collaborator: American Cancer Society, Inc. (Other)
• Enrollment: 3
• Location: 1
• Arms: 2
• Duration (Months): 46.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study will help researchers learn about the best dose of radiation to be used when treating large early stage non-small cell lung cancer (NSCLC) with a treatment called stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC show positive response. But, for large early stage NSCLC it may be better to give different SABR doses than what is used in routine early stage NSCLC treatment. It is not understood which dose is best for treating large early stage NSCLC. Therefore, this study can help researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can increase the chance of cure for large early stage NSCLC.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Radiation: Image Guided Stereotactic Ablative Radiotherapy	N/A

Detailed Description

Treatment Plan:

7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular intensity-modulated radiation therapy (IMRT).

• Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal planning target volume (PTV) coverage is achieved; but the 7.5 Gy x 10 daily fractions schedule is preferred.

• All doses are prescribed to the tumor periphery.

For this protocol, patients will be followed only up to 2 years post radiation therapy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Clinical Trial of Image Guided Stereotactic Ablative Radiotherapy (SABR) for T2 and Microscopic T3 (PL3), N0,M0 Non-small Cell Lung Cancer (NSCLC)
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Jul 7, 2016
• Actual Study Completion Date: Jul 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A - 7.5 Gy x 10 daily fractions Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.	Radiation: Image Guided Stereotactic Ablative Radiotherapy; Other Names: SABR
Experimental: B - 12 Gy x 5 daily fractions Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved	Radiation: Image Guided Stereotactic Ablative Radiotherapy; Other Names: SABR

Outcome Measures

Primary Outcome Measures

1. Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC [2 years]

Secondary Outcome Measures

1. Best Response [2 years]

   To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Non-Small Cell Lung Cancer

• T2N0M0 or T3(PL3)N0M0 or Locally recurrent ≤ 7 cm

• Surgically inoperable

• ECOG Performance 0-2

Exclusion Criteria:

• Pacemaker on the same side of the tumor

• Pregnant

• Infection that requires IV antibiotics

• Concomitant or adjuvant anti-neoplastic chemotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Virginia University Hospitals Mary Babb Randolph Cancer Center	Morgantown	West Virginia	United States	26506

Sponsors and Collaborators

• West Virginia University
• American Cancer Society, Inc.

Investigators

• Principal Investigator: Malcolm Mattes, MD, West Virginia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: West Virginia University
• ClinicalTrials.gov Identifier: NCT02262000
• Other Study ID Numbers: WVU010513
• First Posted: Oct 10, 2014
• Last Update Posted: Jan 22, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by West Virginia University: Non Small Cell Lung Cancer; Surgically inoperable; Radiation Therapy
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

Participant Flow

Arm/Group Title	A - 7.5 Gy x 10 Daily Fractions	B - 12 Gy x 5 Daily Fractions
Arm/Group Description	Radiotherapy: 7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular intensity-modulated radiation therapy (IMRT) at West Virginia University. Image Guided Stereotactic Ablative Radiotherapy	Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal planning target volume (PTV) coverage is achieved Image Guided Stereotactic Ablative Radiotherapy
Period Title: Overall Study
STARTED	3	0
COMPLETED	3	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	A - 7.5 Gy x 10 Daily Fractions	B - 12 Gy x 5 Daily Fractions	Total
Arm/Group Description	Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University. Image Guided Stereotactic Ablative Radiotherapy	Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved Image Guided Stereotactic Ablative Radiotherapy	Total of all reporting groups
Overall Participants	3	0	3
Age (Count of Participants)
<=18 years	0 0%	0 NaN
Between 18 and 65 years	3 100%	3 Infinity
>=65 years	0 0%	0 NaN
Sex: Female, Male (Count of Participants)
Female	2 66.7%	2 Infinity
Male	1 33.3%	1 Infinity
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 NaN
Not Hispanic or Latino	3 100%	3 Infinity
Unknown or Not Reported	0 0%	0 NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN
Asian	0 0%	0 NaN
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN
Black or African American	0 0%	0 NaN
White	3 100%	3 Infinity
More than one race	0 0%	0 NaN
Unknown or Not Reported	0 0%	0 NaN
Region of Enrollment (participants) [Number]
United States	3 100%	3 Infinity

Outcome Measures

1. Primary Outcome

Title	Local Control Rate (Absence of Local Progression) Using SABR for Treatment of NSCLC
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No outcome measures data was available.

Arm/Group Title	A - 7.5 Gy x 10 Daily Fractions	B - 12 Gy x 5 Daily Fractions
Arm/Group Description	Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University. Image Guided Stereotactic Ablative Radiotherapy	Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved Image Guided Stereotactic Ablative Radiotherapy
Measure Participants	0	0

2. Secondary Outcome

Title	Best Response
Description	To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No outcome measures data was available.

Arm/Group Title	A - 7.5 Gy x 10 Daily Fractions	B - 12 Gy x 5 Daily Fractions
Arm/Group Description	Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University. Image Guided Stereotactic Ablative Radiotherapy	Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved Image Guided Stereotactic Ablative Radiotherapy
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No adverse event data was available.
Arm/Group Title	A - 7.5 Gy x 10 Daily Fractions		B - 12 Gy x 5 Daily Fractions
Arm/Group Description	Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University. Image Guided Stereotactic Ablative Radiotherapy		Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved Image Guided Stereotactic Ablative Radiotherapy
All Cause Mortality
	A - 7.5 Gy x 10 Daily Fractions		B - 12 Gy x 5 Daily Fractions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	A - 7.5 Gy x 10 Daily Fractions		B - 12 Gy x 5 Daily Fractions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	A - 7.5 Gy x 10 Daily Fractions		B - 12 Gy x 5 Daily Fractions
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.