Daily vs. Non-Daily SBRT for NSCLC

NCT03624907 | Terminated DMC

• 2 other identifiers: IRB201801625OCR17400
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-small Cell Lung Cancer

Keywords

stereotactic body radiotherapy (SBRT)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Document acute and late toxicity related to treatment

  2 years

• Document patient-reported quality of life before, during, and after treatment

  2 years

• Evaluate circulating tumor DNA

  2 years

• Overall Survival

  2 years

• Progression Free Survival

  2 years

Study Arms (2)

Consecutive Daily Treatment

OTHER

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

Non-Consecutive Daily Treatment

OTHER

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

Interventions

Daily Stereotactic Body Radiotherapy RADIATION

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

Consecutive Daily Treatment

Non-Daily Stereotactic Body Radiotherapy RADIATION

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

Non-Consecutive Daily Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• DiaCarta, Inc.: collaborator

Study Sites (2)

Department of Radiation Oncology Davis Cancer Pavilion

Gainesville, Florida, 32611, United States

Location

University of Florida Health Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anamaria Yeung, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either daily or non-daily stereotactic body radiotherapy (SBRT).

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 10, 2018
• Study Start: October 19, 2018
• Primary Completion: June 16, 2021
• Study Completion: June 16, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)