SRS Study in Patients With Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00489008
First received: June 20, 2007
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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

Condition Intervention Phase
Lung Cancer
Procedure: Stereotactic Body Radiation Therapy (SBRT)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Stereotactic Body Radiotherapy for Stage I (T1-T2, N0, M0), Selective Stage II (Chest Wall T3, N0M0) or Isolated Peripheral Lung Recurrent Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression Free Survival (PFS) at Treated Primary Tumor Site [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 138
Study Start Date: November 2005
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Stereotactic Body Radiation Therapy (SBRT) Stage I NSCLC
Procedure: Stereotactic 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

Experimental: Cohort 2
Stereotactic Body Radiation Therapy (SBRT) Selective Stage II NSCLC
Procedure: Stereotactic 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

Experimental: Cohort 3
Stereotactic Body Radiation Therapy (SBRT) Isolated Peripheral Lung Recurrent NSCLC
Procedure: Stereotactic 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


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 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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:

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489008

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Joe Y. Chang, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00489008     History of Changes
Other Study ID Numbers: 2005-0574, NCI-2012-01495
Study First Received: June 20, 2007
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Non-Small Cell
Stereotactic Body Radiation Therapy
SBRT
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 20, 2014