Recruiting

Radiation Schedules

Sponsor:

University of Rochester

Code:

NCT03706027

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

radiation therapy-3 fractions

Radiation therapy-5 fractions

Study Details

Brief 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. After patients complete radiation treatment, they will follow up with their radiation oncologist.

Conditions

Lung Cancer

Study ID

NCT03706027

Start date

Dec 15, 2018

Status verified date

Jul, 2026

Completion date

Nov 15, 2034

Anticipated

Primary completion date

Nov 15, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Stereotactic body radiotherapy- 3 fractions

active comparator: Stereotactic body radiotherapy- 5 fractions

Interventions

radiation therapy-3 fractions

Radiation therapy given in a 3 fraction schedule (over 3 days). Total dose is 54 Grays.

Radiation therapy-5 fractions

Radiation therapy given in 5 fractions (over 5 days). Total dose is 60 Grays.

Primary outcome measure

  • frequency of grade 3 treatment related toxicities or higher [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Deepinder Singh, MD

585-275-5623deepinder_singh@urmc.rochester.edu

Locations

James P. Wilmot Cancer Center at University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Deepinder Singh, MD

585-275-5623deepinder_singh@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-07-20.