Lung CancerNCT03706027
Study Comparing Two Different Schedules of Radiation for Early-stage Lung Cancer
A study testing radiation therapy-3 fractions and Radiation therapy-5 fractions in people with Lung Cancer, run by University of Rochester at 1 site in United States.
Trial summary
This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment. Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- radiation therapy-3 fractions and Radiation therapy-5 fractions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2018to 15 Nov 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
Deepinder Singh, MD, 585-275-5623, deepinder_singh@urmc.rochester.edu
About this study
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
This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment. Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation. After patients complete radiation treatment, they will follow up with their radiation oncologist.
- Conditions
- Lung Cancer
- Being tested
- radiation therapy-3 fractions, Radiation therapy-5 fractions
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapy-3 fractionsDevice
Radiation therapy given in a 3 fraction schedule (over 3 days). Total dose is 54 Grays.
Radiation therapy-5 fractionsDevice
Radiation therapy given in 5 fractions (over 5 days). Total dose is 60 Grays.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiotherapy- 3 fractions | Active comparator | Not described Receives: Device: radiation therapy-3 fractions |
| Stereotactic body radiotherapy- 5 fractions | Active comparator | Not described Receives: Device: Radiation therapy-5 fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of grade 3 treatment related toxicities or higher
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.
Measured: 1 year
Secondary outcomes (3)
mean survival time of patients with overall survival
The failure event for overall survival is a death due to any cause. Survival time is measured from the date of randomization to the date of death or last follow up.
Measured: 3 years
proportion of patients with disease-free survival
The failure event for disease-free survival is defined as death due to any cause, local failure, marginal failure, involved node failure, regional failure, distant metastasis, or second primary.
Measured: 3 years
proportions of patients with primary tumor control
Marginal failures will be considered events for primary tumor failure. The primary tumor control rate at 1 year will be calculated as the number of patients who do not have a local progression event by the total number of analyzable patients in each arm at 1 year.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start15 Dec 2018
- Primary completion15 Nov 2033 (estimated)
- Study completion15 Nov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepinder P Singh, MD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706027
- Sponsor's protocol ID
- 72835
- Status last verified
- Jul 2026
- First submitted
- 10 Oct 2018
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03706027
- Acronym / sponsor ID
- 72835
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 15 Nov 2033 (estimated)
- Study completion
- 15 Nov 2034 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment. Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation. After patients complete radiation treatment, they will follow up with their radiation oncologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiotherapy- 3 fractions | Active comparator | Device: radiation therapy-3 fractions |
| Stereotactic body radiotherapy- 5 fractions | Active comparator | Device: Radiation therapy-5 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapy-3 fractionsRadiation therapy given in a 3 fraction schedule (over 3 days). Total dose is 54 Grays. | Device | Stereotactic body radiotherapy- 3 fractions |
| Radiation therapy-5 fractionsRadiation therapy given in 5 fractions (over 5 days). Total dose is 60 Grays. | Device | Stereotactic body radiotherapy- 5 fractions |
Primary outcome
frequency of grade 3 treatment related toxicities or higher
Time frame: 1 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.
3 secondary outcomes
mean survival time of patients with overall survival
Time frame: 3 years
proportion of patients with disease-free survival
Time frame: 3 years
proportions of patients with primary tumor control
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiation therapy-3 fractions and Radiation therapy-5 fractions in people with Lung Cancer, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deepinder Singh, MD (585-275-5623, deepinder_singh@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of grade 3 treatment related toxicities or higher (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.