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CompletedNCT00489008Updated Mar 30, 2020

SRS Study in Patients With Non-Small Cell Lung Cancer

A Phase 2 interventional study of Stereotactic Body Radiation Therapy (SBRT) in Lung Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-03-30.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Nov 2005, registered Jun 2007).
Phase
Phase 2
Study type
Interventional
Enrollment
141
Allocation
Non-randomized
Sex
All
01

Study summary

The goal of this clinical research study is to learn if stereotactic body radiotherapy (SBRT) can help to control NSCLC. The safety of SBRT will also be studied.

Objectives:

To assess therapeutic efficacy and toxicities of stereotactic body radiotherapy (SBRT) for patients with medically inoperable stage I (T1-2, N0,M0), selective stage II (chest wall T3, N0M0) or isolated peripheral lung recurrent non-small cell lung cancer (NSCLC).

Primary goal: Improve 2 years progression free survival at the treated primary tumor site.

Secondary goals:

  1. Improve disease free survival, disease specific survival and overall survival at 2 years.
  2. Decrease grade 3 and above acute and/or chronic toxicities.
  3. Collect blood for future biomarkers study
Read the detailed description

Stereotactic body radiotherapy is designed to provide an image guided, more focused, dose escalated radiotherapy over a shorter time frame (1 week rather than 7 weeks) than conventional radiation therapy. The goal of SBRT is to improve tumor control while reducing the side effects.

If you are found to be eligible to take part in this study, you will receive daily SBRT for 4 days in a row over a 45 minute time period. During the treatment, you will lie still on a table for about 45 minutes per day in the same position. The machine will deliver the dose according to the plan developed by the doctor and the dose will be controlled by a computer.

During the treatment, you will be seen by a doctor and research nurse once a week to evaluate possible side effects. A physical exam and a medical history will be done at these visits.

You will be taken off study early if the disease gets worse or intolerable side effects occur.

You will have a follow-up visit 6 weeks after completion of radiotherapy to check for side effects. You will continue to have follow-up visits that will decrease in frequency over time. You will have imaging tests (chest CT or positron emission computed tomography (PET) scan) and routine blood tests (about 2 teaspoons) at these follow-up visits.

This is an investigational study. SBRT is FDA approved for the treatment of lung cancer. About 138 patients will take part in this study. All will be enrolled at MD Anderson.

02

Conditions studied

  • Lung Cancer

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Keywords

  • Lung Cancer
  • Non-Small Cell
  • Stereotactic Body Radiation Therapy
  • SBRT
  • NSCLC
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 141 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Cohort 1: Histologically or cytologically documented NSCLC.
  2. Cohort 1: Inoperable stage IA (T1N0MO), IB (T2N0MO) and selective stage II (T3 due to chest wall involvement, N0M0). Patient refuses surgery is eligible. Secondary lung cancer is eligible if primary cancers have been cured or stable with life expectance longer than 2 years. If primary cancer is lung cancer, patient needs to be lung cancer free for more than 5 year for same histology or more than 2 years for different histology.
  3. Cohort 1: Patients with hilar or mediastinal lymph nodes \<= 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but on-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. Patient who received induction chemotherapy or other systemic therapy are eligible.
  4. Cohort 1: Performance score Karnofsky performance status (KPS) 60-100.
  5. Cohort 2: Histologically or cytologically documented NSCLC.
  6. Cohort 2: Inoperable isolated lung parenchyma recurrent NSCLC without evidence of lymph node or mediastinal involvement (clinical stage T1-2, chest wall involvement T3, N0M0) after surgical resection or definitive radiotherapy with/without chemotherapy. Recurrent disease is defined as NSCLC with same histology, same lobe that recurs within 5 years after initial definitive therapy. Patient refuses surgery is also eligible. Patient received systemic therapy is eligible.
  7. Cohort 2: Performance score KPS 60-100.
  8. Cohort 3: Histologically or cytologically documented NSCLC.
  9. Cohort 3: Previous history of NSCLC that has been cured or stable. New development of inoperable isolated lung parenchyma lesion that has been documented histologically or cytologically as NSCLC without evidence of lymph node or mediastinal involvement (clinical stage T1-2, chest wall involvement T3, N0M0) and not eligible for cohort 1 and recurrent disease as defined in Cohort 2. This includes NSCLC happens within 5 years after initial definitive treatment of prior NSCLC, and/or is located in the different lobes.
  10. (cont.) Cohort 3: Possible stage IV disease is eligible as long as it meets the criteria above since there is no definitive way to confirm it. Patient refuses surgery is eligible. Patient received systemic therapy is eligible.
  11. Cohort 3: Performance score KPS 60-100.

Exclusion criteria

Exclusion Criteria:

  1. Any tumor involving main bronchus, major vessels, heart, esophagus, trachea, carina, spinal cord.
  2. Any tumor that causes collapsed lobe of lung.
  3. Any tumor with malignant pleural effusion.
  4. Direct evidence of hilar, mediastinal lymph node or distant metastasis based on staging work up.
  5. Pregnancy. Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
141 participants (actual)

Study arms

  • Experimental
    Cohort 1

    Stereotactic Body Radiation Therapy (SBRT) Stage I NSCLC

    Procedure: Stereotactic Body Radiation Therapy (SBRT)

  • Experimental
    Cohort 2

    Stereotactic Body Radiation Therapy (SBRT) Selective Stage II NSCLC

    Procedure: Stereotactic Body Radiation Therapy (SBRT)

  • Experimental
    Cohort 3

    Stereotactic Body Radiation Therapy (SBRT) Isolated Peripheral Lung Recurrent NSCLC

    Procedure: Stereotactic Body Radiation Therapy (SBRT)

Interventions

  • ProcedureStereotactic Body Radiation Therapy (SBRT)

    Cohorts 1 \& 2: 50 gray (GY) with 12.5 GY per Fraction for 4 treatments Cohort 3: 40 GY with 10 GY per Fraction for 4 treatments

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS) at Treated Primary Tumor Site

    Progression free survival at the primary site evaluated by series CT of chest with contrast for every follow up (except 6 weeks after radiotherapy) for two years. PET information considered for calculation of PFS particularly for distant metastasis and/or additional lesions. Population proportion for two-year PFS estimated using Clopper-Pearson 95% confidence intervals.

    Time frame: 2 Years

07

Study locations

1 site
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

Publications

  • Sun B, Brooks ED, Komaki R, Liao Z, Jeter M, McAleer M, Balter PA, Welsh JD, O'Reilly M, Gomez D, Hahn SM, Sepesi B, Rice DC, Heymach JV, Chang JY. Long-Term Outcomes of Salvage Stereotactic Ablative Radiotherapy for Isolated Lung Recurrence of Non-Small Cell Lung Cancer: A Phase II Clinical Trial. J Thorac Oncol. 2017 Jun;12(6):983-992. doi: 10.1016/j.jtho.2017.02.018. Epub 2017 Mar 1. PubMed 28259750 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00489008
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Jun 21, 2007
Start date
Nov 21, 2005
Primary completion
Jun 2, 2017
Completion
Jun 2, 2017
Last update
Mar 30, 2020

Study contacts

Joe Y. Chang, MD, PhD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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