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Trial record 1 of 1 for:    NCT00591838
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A Phase I/II Trial of Stereotactic Body Radiation Therapy (SBRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00591838
Recruitment Status : Active, not recruiting
First Posted : January 11, 2008
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The purpose of this study is to use SBRT in patients with early stage lung cancer and find out what effects (good and bad) SBRT has on their cancer. This research is being done because SBRT has not been used very often in patients with early stage lung cancer or in patients with other serious health problems. In addition, this study also will gather information about patient's health and hospitalization history. This information will be used to find out if there are any factors that can help predict recovery or outcome of patients with lung cancer.

Condition or disease Intervention/treatment Phase
Inoperable Stage I/II Non-small Cell Lung Cancer Radiation: Stereotactic Body Radiation Therapy (SBRT) Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Stereotactic Body Radiation Therapy (SBRT) Dose Escalation in the Treatment of Patients With Inoperable Stage I/II Non-Small Cell Lung Cancer Arising Within the Zone of the Proximal Bronchial Tree
Actual Study Start Date : September 21, 2006
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Phase I


Dose Level A 9Gy x 5

Dose Level B 10 Gy x 5

Dose Level C 11 Gy x 5

Dose Level D 12 Gy x 5)

Radiation: Stereotactic Body Radiation Therapy (SBRT)
Experimental: Phase II
Dose will be determined in Phase II portion of study
Radiation: Stereotactic Body Radiation Therapy (SBRT)

Primary Outcome Measures :
  1. Phase I Portion Only: Determine the maximum tolerated dose [ Time Frame: Completion of phase I enrollment ]
  2. Phase I Portion Only: Rate of acute treatment related grade 3 or 4 toxicity [ Time Frame: Up to 100 days ]
    -CTCAE version 3.0 will be used to grade toxicity

  3. Phase I Portion Only: Rate of late treatment related grade 3 or 4 toxicity [ Time Frame: 101 days to 2 years ]
    -CTCAE version 3.0 will be used to grade toxicity

  4. Phase II Portion Only: Determine if the MTD determined in Phase I achieves acceptable local control [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Regional nodal recurrence rate [ Time Frame: 2 years ]
  2. Disseminated recurrence rate [ Time Frame: 2 years ]
  3. Disease-free rate [ Time Frame: 2 years ]
  4. Overall survival rate [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Inclusion Criteria

  • Histologically confirmed non-small cell cancer by biopsy or cytology. Squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar carcinoma, or non-small cell carcinoma (not otherwise specified) are allowed.
  • Staging studies must identify patient as AJCC Stage I or II based on only 1 of following combinations of TNM staging:

    • T1, N0, M0
    • T2 (<=7cm), N0, M0
    • T3 (<=7cm), N0, M0
  • Primary tumor must be arising in one of the following central chest locations:

    • Within or touching the zone of the proximal bronchial tree (a volume 2cm in all directions around the proximal bronchial tree [carina, R & L main bronchi, R & L upper lobe bronchi, intermedius bronchus, R middle lobe bronchus, lingular bronchus, R & L lower lobe bronchi])
    • Adjacent to (within 5 mm) or invading the mediastinal pleura
    • Adjacent to (within 5 mm) or invading the parietal pericardium
  • To differentiate T3 lesions involving the mediastinal pleura from T4 lesions involving major vessels or organs, a chest MRI will be obtained. If any uncertainty remains, the patient will have four-dimensional CT scans (4DCT) in an effort to determine the degree of tumor motion. A freely mobile tumor during ventilation will be judged to be T3 disease.
  • Patients with hilar or mediastinal lymph nodes <=1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with >1cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer.
  • Primary tumor must be technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (potentially curative resection, PCR). However, patients must have underlying physiological medical problems prohibiting PCR (i.e., problems with general anesthesia, the operation, the post-op recovery period, or removal of adjacent functioning lung) or refuse surgery. Deeming a patient medically inoperable based on pulmonary function for surgical resection may include any of the following: baseline FEV1 <40% predicted; post-operative predicted FEV1 <30% predicted; severely reduced diffusion capacity; baseline hypoxemia and/or hypercapnia; exercise oxygen consumption <50% predicted; severe pulmonary hypertension; diabetes with severe end organ damage; severe cerebral, cardiac, or peripheral vascular disease; or severe chronic heart disease. Any one of these problems will qualify a patient for this trial.
  • Age >=18.
  • Zubrod performance status 0-2.
  • Women of childbearing potential must use effective contraception.
  • No direct evidence of regional or distant metastases after appropriate staging studies. No synchronous primary or prior malignancy in past 2 years except non-melanoma skin cancer or in situ cancer.
  • No previous lung or mediastinal radiation therapy.
  • No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemo, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.
  • No active systemic, pulmonary, or pericardial infection.
  • No pregnant or lactating women.

    • History and Physical Examination, Weight, Zubrod performance status (within 4 weeks pre-study entry)
    • Evaluation by thoracic cancer clinician (within 8 weeks pre-study entry)
    • Pregnancy test, if applicable (serum or urine, within 72 hours prior to treatment start.)
    • CT (preferably with contrast unless medically contraindicated; both lungs, mediastinum, liver, adrenals)
    • PET (using FDG with visualization of primary tumor and draining lymph node basins in hilar and mediastinal regions)
    • Brain MRI or head CT with contrast
    • PFTs - include routine spirometry, lung volumes, diffusion capacity
    • Signed informed consent.

Exclusion Criteria:

There is no exclusion criteria associated with this protocol. Please see the above inclusion criteria.-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591838

United States, Missouri
Washington University School
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Jeffrey D Bradley, MD Washington University School of Medicine

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00591838     History of Changes
Other Study ID Numbers: 06-0691 / 201012832
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Washington University School of Medicine:

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