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Radiation

SBRT + Chemotherapy for Lung Cancer

Phase 1

Waitlist Available

Led By Abraham Wu, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed non-small cell lung cancer

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will help determine if immunologic biomarkers and functional MRI images can help predict response to non-small cell lung cancer treatment and what side effects patients experience.

Who is the study for?

This trial is for adults with inoperable, locally-advanced non-small cell lung cancer (NSCLC) who haven't had surgery or chemo for their current cancer. They must be fit enough for treatment (Karnofsky Performance Status ≥70%) and willing to use contraception if of childbearing potential. People can't join if they've had previous lung radiation, are on high-dose steroids, need continuous oxygen, or have certain heart conditions.Check my eligibility

What is being tested?

The study tests whether biomarkers and MRI images can predict how well NSCLC responds to Stereotactic Body Radiation Therapy (SBRT). Patients will receive SBRT alone without chemotherapy and will be monitored to gather information about the effectiveness of this approach from both medical and patient perspectives.See study design

What are the potential side effects?

Possible side effects from SBRT may include fatigue, skin reactions at the treatment site, shortness of breath, chest pain, coughing up blood, difficulty swallowing due to inflammation of the esophagus, and rarely damage to surrounding organs like the heart or lungs.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is confirmed to be non-small cell type.

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I am 18 years old or older.

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I am mostly able to care for myself and carry out daily activities.

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My kidney, liver, and blood counts are within healthy ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

maximum tolerated dose (Cohort A)

Secondary outcome measures

overall survival (Cohorts A & B)

≥ grade 4 or persistent ≥ grade 3 late toxicities (Cohorts A & B)

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593

21%

Anemia

18%

Neutropenia

15%

Hypoalbuminemia

15%

White blood cell decreased ( leukopenia)

15%

Diarrhea

12%

Liver Dysfunction

Hand-Foot

Bleeding

Stroke

Abdominal Infection

Ileus

Mucositis

Edema

Dermatitis

Platelet count decreased ( Thrombocytopenia)

100%

80%

60%

40%

20%

Study treatment Arm

Gem + Xeloda + SBRT

Trial Design

2Treatment groups

Experimental Treatment

Group I: B) 3-5cm OR Chemo ineligibleExperimental Treatment1 Intervention

Using intensity-modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT), the choice of which is determined by the radiation oncologist, patients will be treated in < 5 fractions every other day. The total treatment dose will be between 45 and 54 Gy in < 5 fractions per standard of care. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy at the discretion of their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year. FDG PET/CT scans and Pulmonary Function Tests (PFTs) will be obtained at 3 months and 9 months after SBRT.

Group II: A) >5cm,Chemo eligible (closed to accrual)Experimental Treatment2 Interventions

Patients will receive five fractions of either 8, 10, or 12 Gy to the gross tumor only. Following SBRT patients will be evaluated by their medical oncologist for consideration of adjuvant chemotherapy, starting 6-8 weeks post-RT. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy by their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy (SBRT)

2018

Completed Phase 2

~740

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,771 Total Patients Enrolled

Abraham Wu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

55 Total Patients Enrolled

Andreas Rimner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

11 Previous Clinical Trials

373 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy (SBRT) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT01899989 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: A) >5cm,Chemo eligible (closed to accrual), B) 3-5cm OR Chemo ineligible

Non-Small Cell Lung Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SBRT) Highlights & Side Effects. Trial Name: NCT01899989 — Phase 1

Stereotactic Body Radiation Therapy (SBRT) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01899989 — Phase 1

Frequently Asked Questions

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

Does the FDA recognize Stereotactic Body Radiation Therapy (SBRT) as a valid treatment?

"The SBRT intervention has limited clinical data surrounding its safety and efficacy, so it was rated a 1 on our scale."

Answered by AI

To what ailments is Stereotactic Body Radiation Therapy (SBRT) most often prescribed?

"Stereotactic Body Radiation Therapy (SBRT) is traditionally used to combat melanoma. Furthermore, it has been noted as a successful intervention for several other maladies including metastatic neoplasms, lymphomas, and non-Hodgkin's disease."

Answered by AI

How many participants has this research project enrolled so far?

"This clinical trial is no longer enrolling patients, having last been updated on October 20th 2022. Alternately, 1950 studies are currently accepting participants who have carcinoma, non-small-cell lung and 1136 trials that involve Stereotactic Body Radiation Therapy (SBRT) are recruiting volunteers."

Answered by AI

What is the extent of implementation for this clinical trial?

"To date, 8 sites are participating in the study. These include Memorial Sloan Kettering Cancer Center at Basking Ridge in Basking Ridge and Mercy Medical Center in Rockville Centre as well as 6 other clinical trial locations."

Answered by AI

Is this research endeavor actively recruiting participants?

"According to clinicaltrials.gov, this particular medical trial is not presently accepting patients for the study that was first posted on July 5th 2013 and updated last October 20th 2022. However, there are 3,086 other studies actively recruiting participants at present."

Answered by AI

Could you elaborate on the prior experimentation that has been done in regard to Stereotactic Body Radiation Therapy (SBRT)?

"Presently, there are 1136 trials assessing the efficacy of Stereotactic Body Radiation Therapy (SBRT). Of those studies, 379 have entered Phase 3. While most of these SBRT experiments take place in Shanghai, there are 64993 different medical locales conducting research for this therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer

2013. "Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01899989.

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