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

NCT03706027 | Recruiting FDA Device

• 1 other identifier: 72835
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (3)

• mean survival time of patients with overall survival

  3 years

• proportion of patients with disease-free survival

  3 years

• proportions of patients with primary tumor control

  3 years

Study Arms (2)

Stereotactic body radiotherapy- 3 fractions

ACTIVE COMPARATOR

Device: radiation therapy-3 fractions

Stereotactic body radiotherapy- 5 fractions

ACTIVE COMPARATOR

Device: Radiation therapy-5 fractions

Interventions

radiation therapy-3 fractions DEVICE

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

Stereotactic body radiotherapy- 3 fractions

Radiation therapy-5 fractions DEVICE

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

Stereotactic body radiotherapy- 5 fractions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

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

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Deepinder Singh, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: December 15, 2018
• Primary Completion: November 15, 2025
• Study Completion (Estimated): November 15, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)