Shorter radiation course may reduce side effects for lung cancer patients
NCT ID NCT03706027
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This study compares two different schedules of stereotactic body radiotherapy (SBRT) for people with early-stage non-small-cell lung cancer. Patients are randomly assigned to receive radiation over 3 days or 5 days. The main goal is to see if one schedule causes fewer severe side effects than the other. Participants are followed by their radiation oncologist after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stereotactic body radiotherapy (SBRT) given in either 3 fractions (54 Gy) or 5 fractions (60 Gy)
- What this could lead to
- If successful, this could show that a shorter 3-day radiation course causes fewer severe side effects than a 5-day course, potentially becoming the preferred treatment schedule.
- What could go wrong
- This is a phase II trial with only 100 participants, so results may not apply to all patients. The study focuses on side effects, not cure rates, and longer follow-up is needed to confirm safety and effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2018
- Expected to finish
-
Nov 2034
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histological confirmation of non-small cell cancer will not be required as primary goal of this phase II trial is to look at toxicity. However, all primary non-small cell lung cancers otherwise of following types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified. * Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC stage I or II based on only one of the following combinations of TNM staging: * T1, N0, M0 * T2 (≤ 5 cm), N0, M0 * Patients with hilar or mediastinal lymph nodes ≤ 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with \> 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. All patients with suspicious nodes will be evaluated for mediastinal and hilar staging with bronchoscopy and (if amenable) bronchoscopic biopsy (preferably navigational biopsy and/or endobronchial US guided biopsy). * Zubrod performance status 0-2 within 4 weeks of study entry. * Women of childbearing potential and male participants must use an effective contraceptive method. * Evaluations required at time of study entry: * History \& Physical by a radiation oncologist within 4 weeks of study entry; * Vitals within 4 weeks of study entry; * Evaluation by a thoracic surgeon (either via clinical examination and/or input at multidisciplinary tumor board) prior to study entry; * PFTs: Routine spirometry, lung volumes, diffusion capacity, and arterial blood gases within 8 weeks prior to study entry; * CT Chest within 6 weeks of study entry (preferably with intravenous contrast, unless medically contraindicated) - to include the entirety of both lungs, the mediastinum, liver, and adrenal glands; primary tumor dimension will be measured on this CT; * Whole body positron emission tomography (PET) scan using FDG with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions within 6 weeks prior to study entry. * Informed consent signed by the subject and a member of the study team. Exclusion Criteria: * Patients with central tumors. Specifically; central location implies a tumor inside the zone of the proximal bronchial tree defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi * Evidence of regional or distant metastases after appropriate staging studies. * Synchronous primary NSCLC. * Those with prior malignancy in the past 2 years other than non-melanomatous skin cancer or in situ cancer or thyroid cancer. * Previous lung or mediastinal radiotherapy. * Plans for the patient to receive concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol. * Patients with active systemic, pulmonary or pericardial infection. * Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Lung cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
James P. Wilmot Cancer Center at University of Rochester Medical Center
RECRUITINGRochester, New York, 14642, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug shrink advanced solid tumors?
- A spoonful of olive oil before lung surgery: a new shield against a rare complication?
- Can a targeted drug delivery system shrink lung tumors?
- Can a new drug shrink tumors that resist standard care?
- Mobile lung cancer clinics aim to close rural screening gap
- Can protein patterns in stored tumors point to new treatment targets?