Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Comparing two schedules of radiation for early-stage lung cancer

Official title: Three- Versus Five-Fraction Regimens of Stereotactic Body Radiotherapy for Peripheral Early-Stage Non-Small-Cell Lung Cancer: A Prospective Randomized Phase II Study

Run by University of Rochester · NCT03706027 · Data updated 2026-11-12

This study is testing whether different schedules of radiation therapy for early-stage lung cancer cause different side effects for patients.

More Lung Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity of Rochester
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Rochester, New York)
StatusRecruiting
StartedDecember 15, 2018
Main results expectedNovember 15, 2033
Study endsNovember 15, 2034
Registry record updatedJuly 20, 2026
Trial IDNCT03706027 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with early-stage non-small cell lung cancer classified as AJCC stage I or II.

Probably not a fit

Patients with advanced lung cancer or those who do not meet the specific staging criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine if the side effects experienced by patients undergoing radiation therapy for early-stage lung cancer differ based on the treatment schedule. Participants will be randomly assigned to receive either a 3 Fraction or a 5 Fraction schedule of radiation therapy. Following the completion of their treatment, patients will have follow-up appointments with their radiation oncologist to monitor any side effects and overall health outcomes.

Why it matters

Potential benefit: If successful, this study could help optimize radiation treatment schedules to minimize side effects for lung cancer patients.

How similar studies have gone: Other studies have explored different radiation schedules, but this specific comparison of 3 vs. 5 fractions for early-stage lung cancer is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • James P. Wilmot Cancer Center at University of Rochester Medical Center
    Rochester, New York, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.