Daily vs. Non-Daily SBRT for NSCLC

Consecutive Vs. Non-Consecutive Stereotactic Body Radiotherapy For Early Stage Non-Small Cell Lung Cancer

The purpose of this study is to determine if stereotactic body radiotherapy (SBRT) on non-consecutive days will increase the chances of curing non-small cell lung cancer when compared to daily treatment.

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Radiation: Daily Stereotactic Body Radiotherapy; Radiation: Non-Daily Stereotactic Body Radiotherapy

Detailed Description

The purpose of this study is to determine if treatment with stereotactic body radiotherapy (SBRT) on non-consecutive days will improve the chance of curing non-small cell lung cancer compared to treatment with SBRT on consecutive days. In either case, the dose of radiation is the same. Non-consecutive treatments will be at least 40 hours apart and no more than 100 hours apart. The total course of treatment will be 8-12 days. Consecutive treatments will be daily over 4-5 days within one calendar week. The total course of treatment will be 4-5 days.

The study team will assess if DNA from the tumor can be found in the blood to determine which patients respond quickest to radiotherapy. These results will not be made available to participants and will not change treatment.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Department of Radiation Oncology Davis Cancer Pavilion
    • Jacksonville, Florida, United States, 32206
      • University of Florida Health Proton Therapy Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥ 18 years of age (no upper age limit).
• A diagnosis of non-small cell lung cancer, T1-2 N0 M0 either with histologic confirmation or with documented interval growth of the index lesion on two interval computed tomography (CT) chest scans and an SUVmax of the lesion ≥ 3.0 on a pretreatment PET scan.
• Patient must be deemed medically inoperable or refuse surgery.
• Radiographic evaluation of the mediastinum and distant sites with a CT scan of the chest and PET scan.
• For T2b N0 patients, radiographic evaluation of the brain with magnetic resonance imaging (MRI) of the brain unless the patient has contraindications to an MRI scan (in which case a CT scan of the head is necessary).
• For central T1 N0 and all T2 N0 patients, pathologic sampling (either via endobronchial ultrasound-guided biopsy [EBUS] or mediastinoscopy) of mediastinal lymph nodes is required.
• ECOG Performance Status 0-2.
• For women of childbearing potential, negative pregnancy test within 2 weeks prior to SBRT treatment.
• Patients must be deemed able to comply with the treatment plan and follow-up schedule.
• Patients must provide specific informed consent prior to study entry.
• Women of childbearing potential and male participants who are sexually active must use adequate contraception during treatment and for 6 weeks following treatment.

Exclusion Criteria:

• Prior history of radiation therapy to the thorax that would likely increase the risk of serious complications from the radiotherapy delivered on this protocol.
• Prior history of lung cancer.
• Currently taking disease-modifying rheumatoid drugs (DMRDs).
• Severe, active co-morbidity, defined as follows:
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. Note, however, that coagulation parameters are not required for entry into this protocol.
• Prior organ transplant.
• Systemic lupus.
• Psoriatic arthritis.
• Known to be HIV positive. HIV-positive patients are known to have worse clinical outcomes, especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Consecutive Daily Treatment; Participant will receive daily stereotactic body radiotherapy at a dose of 48-50 Gy in 4-5 fractions with treatment occurring over 4-5 days	Radiation: Daily Stereotactic Body Radiotherapy; After randomization, participants will receive daily standard of care doses of radiotherapy at treating physicians discretion.
Other: Non-Consecutive Daily Treatment; Participant will receive non-daily stereotactic body radiotherapy at a dose of 48-50 Gy in 4-5 fractions with treatment occurring over 8-12 days	Radiation: Non-Daily Stereotactic Body Radiotherapy; After randomization, participants will receive non-daily standard of care doses of radiotherapy at treating physicians discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two-year control measured by CT (computerized tomography) scan	Control defined as Less than 20% increase in the largest dimension of treated tumor measurable by CT	Two years
Two year control measured by PET (positron emission tomography) scan	Control defined as PET imaging with uptake of a similar intensity as the pretreatment staging PET	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Document acute and late toxicity related to treatment	This will be assessed using the most recent version of the Common Terminology Criteria for Adverse Events (CTCAE).	2 years
Document patient-reported quality of life before, during, and after treatment	This will be done using quality of life surveys	2 years
Evaluate circulating tumor DNA	This will be done by collecting blood prior to, during, and after treatment	2 years
Overall Survival	Tracked through patient follow up	2 years
Progression Free Survival	Tracked through patient follow up	2 years

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: DiaCarta, Inc.
• Investigators: Principal Investigator: Anamaria Yeung, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2018
• Primary Completion (Actual): June 16, 2021
• Study Completion (Actual): June 16, 2021

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: stereotactic body radiotherapy (SBRT)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IRB201801625; OCR17400 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No