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A Phase I/II Trial of Stereotactic Body Radiation Therapy (SBRT)
This study is currently recruiting participants.
Verified by Washington University School of Medicine, February 2009
First Received: December 31, 2007   Last Updated: February 3, 2009   History of Changes
Sponsored by: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00591838
  Purpose

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 Intervention Phase
Inoperable Stage I/II Non-Small Cell Lung Cancer
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Phase I
Phase II

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Phase I: The primary objective of Phase I is to estimate the rate of acute and late treatment-related grade 3 or 4 toxicity (per CTCAE, v.3.0) Or any other grade 4 or 5 toxicity attributed to the therapy. [ Time Frame: In order to establish the maximum tolerated dose (MTD) of radiotherapy, that can be delivered using stereotactic body radiation therapy for central lung tumors, we hope to control the dose limiting toxicity . ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The primary endpoint of Phase II is to estimate the local control rate at two years and the secondary endpoint of Phase II include the rates of local recurrence, regional recurrence, disease-free and overall survival at two years. [ Time Frame: This phase II study aims to improve the two-year local control rate from 60% to 80%, assuming that a control rate less than 60% is not of interest and that a 2-year control rate of 80% or more would definitely be of interest. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: August 2006
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Stereotactic Body Radiation Therapy (SBRT)

    Phase I Dose level A - 9GYx5 Dose level B - 10GYx5 Dose level C - 11GYX5 Dose Level D - 12GYX5

    Phase II Deliver maximum tolerated dose from Phase I portion to 43 patients with objective of determining local control rate and patterns of recurrence disease-free and overall survival rates at two years.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (<5cm), N0, M0
    • T3 (<5cm), 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]) - see Figure 1
    • Adjacent to (within 5 mm) or invading the mediastinal pleura
    • Adjacent to (within 5 mm) or invading the parietal pericardium
  • 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). 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/Men 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.
  • PRESTUDY REQUIREMENTS:

    • 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.)
    • CXR*
    • 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)
    • PFTs - include routine spirometry, lung volumes, diffusion capacity,
    • CCI, CIRS-G, hospitalization history (strongly encouraged, not required) within 45 days pre-study entry.
  • Signed informed consent.

Exclusion Criteria:

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591838

Contacts
Contact: Jeffrey D. Bradley, MD (314) 362-8525 bradley@radonc.wustl.edu

Locations
United States, Missouri
Washington University School Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jeffrey D Bradley, MD     314-362-8525     bradley@radonc.wustl.edu    
Contact: Linda M Brockman     (314) 454-7986     brockmal@ccadmin.wustl.edu    
Principal Investigator: Jeffrey D Bradley, MD            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jeffrey D Bradley, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine ( Jeffrey Bradley, M.D. )
Study ID Numbers: 06-0691
Study First Received: December 31, 2007
Last Updated: February 3, 2009
ClinicalTrials.gov Identifier: NCT00591838     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
SBRT

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009