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Radiation

Radiation Therapy + Surgery for Lung Cancer

Q: Are any new volunteers still being accepted for this research endeavor?

Clinicaltrials.gov reveals that this clinical trial is accepting patients, having been first published in December 2017 and most recently updated on May 2nd 2022.

Q: Has the FDA sanctioned Stereotactic Body Radiation Therapy for medical use?

The safety of Stereotactic Body Radiation Therapy was rated a 2, as this is a Phase 2 trial that has not yet demonstrated therapeutic efficacy but does have some evidence of its security.

Q: How many participants is the research team recruiting for this experiment?

Indeed, the information hosted on clinicaltrials.gov affirms that this medical experiment has opened recruitment and is actively seeking candidates. The trial was initially launched on December 18th 2017 and last updated on May 2nd 2022; 57 participants need to be sourced from one centre for participation in the study.

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 below

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I am able to get out of my bed or chair and move around.

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I am fit for surgery, specifically a lobectomy or wedge resection.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 • NCT02045446

79%

Cough

64%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Chest pain

21%

Anorexia

21%

Lymphocyte count decreased

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

Alopecia

Dehydration

Blurred vision

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Otitis externa

Creatinine increased

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Hypertension

Tachycardia

Lung infection

Neuropathy

Pleuritic pain

Neutropenia

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,838 Total Patients Enrolled

Anurag SinghPrincipal InvestigatorRoswell Park Cancer Institute

9 Previous Clinical Trials

196 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT03348748 — Phase < 1

Non-Small Cell Lung Cancer Research Study Groups: Study 2 (lowest-dose of SBRT, surgery), Study 1 (highest-dose of SBRT, surgery), Study 3 (lowest- or higher-dose of SBRT, surgery)

Non-Small Cell Lung Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT03348748 — Phase < 1

Stereotactic Body Radiation Therapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03348748 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new volunteers still being accepted for this research endeavor?

"Clinicaltrials.gov reveals that this clinical trial is accepting patients, having been first published in December 2017 and most recently updated on May 2nd 2022."

Answered by AI

Has the FDA sanctioned Stereotactic Body Radiation Therapy for medical use?

"The safety of Stereotactic Body Radiation Therapy was rated a 2, as this is a Phase 2 trial that has not yet demonstrated therapeutic efficacy but does have some evidence of its security."

Answered by AI

How many participants is the research team recruiting for this experiment?

"Indeed, the information hosted on clinicaltrials.gov affirms that this medical experiment has opened recruitment and is actively seeking candidates. The trial was initially launched on December 18th 2017 and last updated on May 2nd 2022; 57 participants need to be sourced from one centre for participation in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer

2017. "Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03348748.