Daily vs. Non-Daily SBRT for NSCLC

NCT ID: NCT03624907

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-19
• Study Completion Date: 2021-06-16

Brief Summary

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.

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Daily Stereotactic Body Radiotherapy

Intervention Type: RADIATION

After randomization, participants will receive daily standard of care doses of radiotherapy at treating physicians discretion.

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

Group Type: OTHER

Non-Daily Stereotactic Body Radiotherapy

Intervention Type: RADIATION

After randomization, participants will receive non-daily standard of care doses of radiotherapy at treating physicians discretion.

Interventions

Daily Stereotactic Body Radiotherapy

After randomization, participants will receive daily standard of care doses of radiotherapy at treating physicians discretion.

Intervention Type: RADIATION

Non-Daily Stereotactic Body Radiotherapy

After randomization, participants will receive non-daily standard of care doses of radiotherapy at treating physicians discretion.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DiaCarta, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anamaria Yeung, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Department of Radiation Oncology Davis Cancer Pavilion

Gainesville, Florida, United States

University of Florida Health Proton Therapy Institute

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

OCR17400

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201801625

Identifier Type: -

Identifier Source: org_study_id