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Radiation
Radiation Therapy + Surgery for Lung Cancer
Phase < 1
Waitlist Available
Led By Anurag Singh
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Participant is able to undergo surgery (planned lobectomy or wedge resection)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing if radiation therapy followed by surgery can effectively treat patients with early to mid-stage non-small cell lung cancer.
Who is the study for?
This trial is for patients with stage I-IIIA non-small cell lung cancer who can undergo surgery. They must understand the study, have been cleared for surgery, agree to use contraception if of child-bearing potential, and have an ECOG status of <=2. Excluded are those unable to cooperate with SBRT treatment, on other antineoplastic therapies (except neoadjuvant therapy), or with certain prior treatments.Check my eligibility
What is being tested?
The trial tests stereotactic body radiation therapy followed by surgery in treating early-stage lung cancer. It aims to see how precisely targeting high-dose radiation at the tumor before surgical removal affects outcomes while minimizing damage to healthy tissue.See study design
What are the potential side effects?
Potential side effects include typical risks associated with radiation such as skin irritation, fatigue, and inflammation around the treated area. Surgery may lead to complications like infection, bleeding, pain at the incision site and general anesthesia risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
Select...
I am fit for surgery, specifically a lobectomy or wedge resection.
Select...
I have been or will be approved for surgery by the time I join the trial, and my tests from the last 45 days are valid for this clearance.
Select...
My diagnosis is non-small cell lung cancer at stage I, II, or IIIa.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
Secondary outcome measures
Overall survival
Progression free survival
Other outcome measures
Change in the mediators of tumor antigen presentation, co-stimulatory molecules, and immune effector cell populations assessed using multicolor flow cytometry, immunohistochemistry, and enzyme-linked immunosorbent assay (ELISA)
Factors associated with T cell immunity in pathologic specimens
Incidence of adverse events assessed using the NCI CTCAE v4.0
Side effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544679%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Back pain
29%
Anemia
29%
Vomiting
21%
Anorexia
21%
Lymphocyte count decreased
21%
Chest pain
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Creatinine increased
7%
Alopecia
7%
Confusion
7%
Sinusitis
7%
Dysgeusia
7%
Hemorrhoids
7%
Dementia
7%
Productive cough
7%
Dysuria
7%
Throat pain
7%
Hearing impaired
7%
Rash
7%
Bone marrow biopsy
7%
Hypernatremia
7%
Eye pain
7%
Tachycardia
7%
Lung infection
7%
Amnesia
7%
Neuropathy
7%
Dehydration
7%
Pneumonitis
7%
Pleuritic pain
7%
Otitis externa
7%
White blood cell count decreased
7%
Neutropenia
7%
Hypertension
7%
Blurred vision
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy
Trial Design
3Treatment groups
Experimental Treatment
Group I: Study 3 (lowest- or higher-dose of SBRT, surgery)Experimental Treatment4 Interventions
Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Group II: Study 2 (lowest-dose of SBRT, surgery)Experimental Treatment4 Interventions
Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Group III: Study 1 (highest-dose of SBRT, surgery)Experimental Treatment4 Interventions
Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
404 Previous Clinical Trials
31,281 Total Patients Enrolled
Anurag SinghPrincipal InvestigatorRoswell Park Cancer Institute
9 Previous Clinical Trials
196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to get out of my bed or chair and move around.I had chemotherapy for another cancer but have been cancer-free for over 3 years.I am fit for surgery, specifically a lobectomy or wedge resection.I have been or will be approved for surgery by the time I join the trial, and my tests from the last 45 days are valid for this clearance.My cancer is at stage IIIb.I plan to receive other cancer treatments while on this trial, except at disease progression.I do not have any ongoing infections.I have had radiation therapy on the lung or chest area affected by cancer.I have received initial treatment for stage IIIa cancer.My diagnosis is non-small cell lung cancer at stage I, II, or IIIa.I cannot undergo SBRT due to an inability to stay still or breathe consistently.I have had surgery for a lung or chest tumor.I am currently pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Study 2 (lowest-dose of SBRT, surgery)
- Group 2: Study 1 (highest-dose of SBRT, surgery)
- Group 3: Study 3 (lowest- or higher-dose of SBRT, surgery)
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.
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