NCT00489008

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2017

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

11.5 years

First QC Date

June 20, 2007

Last Update Submit

March 26, 2020

Conditions

Lung Cancer

Keywords

Lung CancerNon-Small CellStereotactic Body Radiation TherapySBRTNSCLC

Outcome Measures

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.

    2 Years

Study Arms (3)

Cohort 1

EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT) Stage I NSCLC

Procedure: Stereotactic Body Radiation Therapy (SBRT)

Cohort 2

EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT) Selective Stage II NSCLC

Procedure: Stereotactic Body Radiation Therapy (SBRT)

Cohort 3

EXPERIMENTAL

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

Procedure: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT)PROCEDURE

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

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cohort 1: Histologically or cytologically documented NSCLC.
  • 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.
  • 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.
  • Cohort 1: Performance score Karnofsky performance status (KPS) 60-100.
  • Cohort 2: Histologically or cytologically documented NSCLC.
  • 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.
  • Cohort 2: Performance score KPS 60-100.
  • Cohort 3: Histologically or cytologically documented NSCLC.
  • 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.
  • (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.
  • Cohort 3: Performance score KPS 60-100.

You may not qualify if:

  • Any tumor involving main bronchus, major vessels, heart, esophagus, trachea, carina, spinal cord.
  • Any tumor that causes collapsed lobe of lung.
  • Any tumor with malignant pleural effusion.
  • Direct evidence of hilar, mediastinal lymph node or distant metastasis based on staging work up.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 28259750DERIVED

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Joe Y. Chang, MD, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 21, 2007

Study Start

November 21, 2005

Primary Completion

June 2, 2017

Study Completion

June 2, 2017

Last Updated

March 30, 2020

Record last verified: 2020-03

Locations

US(1)