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Radiation Schedules for Early-Stage Lung Cancer

This study is looking at two different ways to give radiation therapy for early-stage lung cancer. You would be randomly assigned to receive either radiation therapy given over 3 days (3 fractions) or radiation therapy given over 5 days (5 fractions). The main goal is to see if the type of side effects you experience from radiation is different between these two schedules. This study is for adults with certain types of non-small cell lung cancer. The study aims to enroll 100 participants, but its current recruitment status is unclear.

Study design
This is an interventional study where 100 participants will be randomly assigned to one of two radiation therapy schedules.
What's involved
You will receive radiation treatment over 3 or 5 days, and then follow up with your radiation oncologist. Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 1 year after treatment to check for side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03706027

Study Comparing Two Different Schedules of Radiation for Early-stage Lung Cancer

Recruiting
NAAges 18+InterventionalTreatment
University of Rochester
~100 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:radiation therapy-3 fractionsRadiation therapy-5 fractions

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
frequency of grade 3 treatment related toxicities or higher
Measured over 1 year

Conditions

Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
New York1

Who to contact

Deepinder Singh, MD
[email protected]
585-275-5623
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • frequency of grade 3 treatment related toxicities or higher1 year

    Toxicities will be assessed using the National Cancer Institute common toxicities criteria version 4.0. The rates of grade 3 or higher adverse events at 1 year will be calculated as the proportion of patients who have any adverse event of interest by the end of year 1 among the total analyzable patients in each arm.