Clinical trial NCT03624907: Daily vs. Non-Daily SBRT for NSCLC
Official title: Consecutive Vs. Non-Consecutive Stereotactic Body Radiotherapy For Early Stage Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: stereotactic body radiotherapy (SBRT)
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: DiaCarta, Inc.
First posted: 2018-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either daily or non-daily stereotactic body radiotherapy (SBRT).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Two-year control measured by CT (computerized tomography) scan
timeFrame: Two years
measure: Two year control measured by PET (positron emission tomography) scan
timeFrame: Two years
Secondary outcomes:
measure: Document acute and late toxicity related to treatment
timeFrame: 2 years
measure: Document patient-reported quality of life before, during, and after treatment
timeFrame: 2 years
measure: Evaluate circulating tumor DNA
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
measure: Progression Free Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Department of Radiation Oncology Davis Cancer Pavilion
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Anamaria Yeung, MD
role: PRINCIPAL_INVESTIGATOR
References: