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Post-Surgery Stereotactic Body Radiation for Lung Cancer

Q: Are there any remaining opportunities for participants to join this experiment?

Affirmative. Clinicaltrials.gov's records show that this medical experiment, initially posted on November 6th 2019, is still actively recruiting participants. Approximately 50 volunteers are needed from a single location.

Q: To what extent might Stereotactic Body Radiation Therapy potentially be harmful to patients?

While limited data suggests that Stereotactic Body Radiation Therapy may be safe and effective, our team at Power assigned a score of 1 due to this being an early stage trial.

Q: What is the current cohort size of this research trial?

Indeed, the information hosted on clinicaltrials.gov confirms that this medical trial is actively seeking participants. This study was first posted on November 6th 2019 and the most recent update occured on May 2nd 2022; 50 patients are currently required from a single medical facility.

Phase 1

Recruiting

Led By Anurag K 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 =< 2

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing the side effects of single fraction stereotactic body radiation therapy after surgery in treating patients with non-small cell lung cancer.

Who is the study for?

This trial is for adults with non-small cell lung cancer who've had surgery to remove it but might still have some cancer cells near the edges of where the tumor was or in certain lymph nodes. They should be able to do most activities on their own (ECOG <=2) and agree to birth control if they can have children. People can't join if they're pregnant, nursing, had prior radiation in that area, can't stay still for treatment, or are unable to follow study rules.Check my eligibility

What is being tested?

The trial tests a single high-dose radiation treatment called Stereotactic Body Radiation Therapy (SBRT) after lung cancer surgery. It's designed to see if one big dose can kill leftover cancer cells without harming too much healthy tissue. Patients will also fill out questionnaires about their quality of life before and after treatment.See study design

What are the potential side effects?

Possible side effects from SBRT may include fatigue, skin reactions at the treated site, shortness of breath due to inflammation or damage to normal lung tissue around the tumor site, chest pain, and coughing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of my waking hours.

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

Feasibility of single fraction SBRT

Incidence of grade 3 or greater toxicities

Secondary outcome measures

In-field failure (IFF) rate

Quality of life (QoL)

Time to initiation of systemic treatment (TST)

Other outcome measures

Change in immune markers

Overall survival (OS)

Progression free survival (PFS)

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

Creatinine increased

Otitis externa

Dehydration

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Blurred vision

Tachycardia

Lung infection

Neuropathy

Hypertension

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

1Treatment groups

Experimental Treatment

Group I: Treatment (SBRT)Experimental Treatment3 Interventions

Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,757 Total Patients Enrolled

Anurag K SinghPrincipal InvestigatorRoswell Park Cancer Institute

5 Previous Clinical Trials

1,864 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04073745 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: Treatment (SBRT)

Non-Small Cell Lung Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT04073745 — Phase 1

Stereotactic Body Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04073745 — Phase 1

Frequently Asked Questions

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

Are there any remaining opportunities for participants to join this experiment?

"Affirmative. Clinicaltrials.gov's records show that this medical experiment, initially posted on November 6th 2019, is still actively recruiting participants. Approximately 50 volunteers are needed from a single location."

Answered by AI

To what extent might Stereotactic Body Radiation Therapy potentially be harmful to patients?

"While limited data suggests that Stereotactic Body Radiation Therapy may be safe and effective, our team at Power assigned a score of 1 due to this being an early stage trial."

Answered by AI

What is the current cohort size of this research trial?

"Indeed, the information hosted on clinicaltrials.gov confirms that this medical trial is actively seeking participants. This study was first posted on November 6th 2019 and the most recent update occured on May 2nd 2022; 50 patients are currently required from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer

2019. "Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04073745.