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Radiation Therapy
Radiation Schedules for Early-Stage Lung Cancer
N/A
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with hilar or mediastinal lymph nodes ≤ 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0
Patients with primary non-small cell lung cancers of the following types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is looking at whether people have different side effects from radiation depending on how often they have it.
Who is the study for?
This trial is for adults with early-stage non-small cell lung cancer, specifically certain types of squamous cell carcinoma, adenocarcinoma, and others without spread to lymph nodes or other organs. Participants should be in fair health and not pregnant. They must agree to use contraception and have no recent history of other cancers or prior chest radiation.Check my eligibility
What is being tested?
The study compares two schedules of radiation therapy for treating lung cancer: one group will receive three fractions (doses) while the other gets five fractions. The aim is to see if side effects differ between these two treatment schedules.See study design
What are the potential side effects?
Radiation therapy can cause skin irritation at the treatment site, fatigue, shortness of breath, coughing, and may affect normal lung tissue leading to inflammation known as pneumonitis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymph nodes in the chest area are normal size and show no signs of cancer on a PET scan.
Select...
My lung cancer is one of the specified types (e.g., squamous, adenocarcinoma).
Select...
My cancer is early stage, not spread to lymph nodes or other parts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
frequency of grade 3 treatment related toxicities or higher
Secondary outcome measures
mean survival time of patients with overall survival
proportion of patients with disease-free survival
proportions of patients with primary tumor control
Trial Design
2Treatment groups
Active Control
Group I: Stereotactic body radiotherapy- 3 fractionsActive Control1 Intervention
Group II: Stereotactic body radiotherapy- 5 fractionsActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will be receiving cancer treatment alongside this study.My lymph nodes in the chest area are normal size and show no signs of cancer on a PET scan.My scans show large lymph nodes but biopsies confirm they are not cancerous.My cancer has spread to other parts of my body.I have been diagnosed with more than one lung cancer at the same time.I have had radiation therapy on my chest area before.I currently have an infection in my body, lungs, or around my heart.My lung cancer is one of the specified types (e.g., squamous, adenocarcinoma).My cancer is early stage, not spread to lymph nodes or other parts.I can take care of myself and am up and about more than 50% of my waking hours.I have completed all required evaluations for the study, including a physical exam, vitals check, and various scans.My tumor is located in a central part of my body.I haven't had cancer in the past 2 years, except for skin, in situ, or thyroid cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic body radiotherapy- 3 fractions
- Group 2: Stereotactic body radiotherapy- 5 fractions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial looking for new participants?
"The listed clinical trial on clinicaltrials.gov is recruiting patients. The trial was first posted on December 15th, 2018 and was most recently updated on August 5th, 2021."
Answered by AI
What is the quota for participants in this experiment?
"That is correct. If you consult clinicaltrials.gov, you will see that the trial in question has been actively recruiting since December 15th, 2018. The 100 participants are needed at a single site."
Answered by AI
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