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Post-Surgery Stereotactic Body Radiation for Lung Cancer

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

Must not have

Patients who undergo sublobar resection but are unable to undergo appropriate N1 and N2 lymph node sampling

Contraindication to SBRT. This includes the inability to cooperate with any aspect of SBRT such as the inability to lie still and breath reproducibly

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a partial lung surgery without full lymph node examination.

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I cannot undergo SBRT due to difficulty lying still or breathing consistently.

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I have had radiation therapy on the same area before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of single fraction SBRT

Incidence of grade 3 or greater toxicities

Secondary study objectives

In-field failure (IFF) rate

Quality of life (QoL)

Time to initiation of systemic treatment (TST)

Other study objectives

Change in immune markers

Overall survival (OS)

Progression free survival (PFS)

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

87%

Fatigue

53%

Nausea

33%

Cough

27%

Pain

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

27%

Anemia

20%

Chills

20%

Dizziness

20%

Edema limbs

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

13%

Dysesthesia

13%

Dysgeusia

13%

Myalgia

13%

Edema

13%

Insomnia

13%

Constipation

13%

Delirium

13%

Skin infection

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Hearing loss

Anxiety

Headaches

Oral lesions

Weakness (facial)

Neutrophil count decreased

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Hearing impaired

Hypernatremia

Creatinine increased

Headache

Death NOS

Gait disturbance

Nasal congestion

Fever

Tremor

Urinary urgency

Hypoxic respiratory failure

Amnesia

Photophobia

Pleural effusion

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Muscle weakness

Erythema multitforme

Lung infection

Hypertension

Allergy (seasonal)

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Chemotherapy

Stereotactic Body Radiation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~790

0 / 4Eligibility criteria met