Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLC (SBF-NSCLC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jill Deluca, Indiana University School of Medicine
ClinicalTrials.gov Identifier:
NCT00246181
First received: October 27, 2005
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

This clinical trial involves a radiation treatment called stereotactic radiotherapy in non-small cell lung cancer patients who have been determined to be ineligible for surgery. This treatment differs from conventional radiotherapy in the number of treatments, the radiation dose given per treatment, and the way the radiation beams are directed toward the cancer.


Condition Intervention Phase
Non-small Cell Lung Cancer
Procedure: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLC

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • The purposes of this research study are (1) to find the highest dose of stereotactic radiotherapy that can safely be used for treatment of early stage non-small cell lung cancer. [ Time Frame: 5 years from enrollment completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • (2) to see what effects (good and bad) stereotactic radiotherapy has on patients and their cancer. [ Time Frame: 5 years from completion enrollment ] [ Designated as safety issue: Yes ]

Enrollment: 117
Study Start Date: December 1999
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: radiation therapy
    Patients will receive 3 fractions
Detailed Description:

The most common treatment for early stage lung cancers is to remove the cancer with surgery. Patients with serious underlying health problems like emphysema, diabetes, or heart disease who develop an early stage lung cancer may not be eligible for the standard surgical treatment. The most common alternative to surgery is conventional radiation treatment called fractionated radiotherapy. "Fractionated radiotherapy" means several weeks of treatment with daily radiation sessions. While this treatment is sometimes successful at killing the cancer, it is not as effective as surgery and may significantly damage the surrounding lung tissue.

Newer treatments using radiotherapy have been developed and used for patients with metastases (spreading cancer) to the lungs. Stereotactic radiotherapy uses a frame to guide highly focused beams of radiation at the cancer while avoiding the normal surrounding tissue. Stereotactic radiotherapy also uses a higher daily dose of radiation. The higher daily dose may be more effective than conventional radiotherapy at killing cancer cells and may also decrease side effects.

  Eligibility

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

Inclusion Criteria:

Consistent with most therapeutic oncology trials, patients are not actively "recruited," but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit.

All patients must be willing and capable to provide informed consent to participate in the protocol.

Eligible patients must have appropriate staging studies identifying them as AJCC stage I (T1 or T2, N0, M0) primary lung carcinoma. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. Histologic confirmation will be required by either biopsy or cytology. The following primary cancer types are eligible: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, bronchioloalveolar cell carcinoma or non-small cell; not otherwise specified.

The primary tumor must be deemed technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection, PCR); however, the patient should have underlying physiological medical problems that would prohibit a PCR due to a low probability of tolerating general anesthesia, the operation, the post-operative recovery period, or the removal of adjacent functioning lung. Standard "cut-off " guidelines regarding surgical resection of NSCLC include the following: Baseline FEV1 <40%, post-operative predicted FEV1 <30%, severely reduced diffusion capacity, baseline hypoxemia and/or hypercapnia and exercise oxygen consumption <50% predicted.

Patients who refuse a PCR due to preference, ideology, emotional or psychological issues, mental illness, or inability to give consent for the PCR and who have no specific accepted medical contraindications for the PCR are not eligible.

Eligible patients should not have had previous lung or mediastinal radiotherapy.

There must be no plans for the patient to receive other concomitant antineoplastic therapy while on this protocol. Patients who have received chemotherapy within 8 weeks of the start date of study are ineligible.

Patients must be able to fit inside the stereotactic body frame and able to undergo a CT or MRI scan in the frame.

The patient's primary tumor must not be larger than 7.0 cm in greatest dimension.

Patients with active systemic, pulmonary, or pericardial infection are ineligible.

Pregnant or lactating women are ineligible. Women/men of reproductive potential may not participate unless they agreed to use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.

Patients must be past their 18th birthday at time of registration. Karnofsky performance status > 60.

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Exclusion Criteria:

See inclusion criteria.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246181

Locations
United States, Indiana
Indiana University, Department of Radiation Oncology
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Jill Deluca
Investigators
Principal Investigator: Ronald McGarry, MD Indiana University - Department of Radiation Oncology
Principal Investigator: Achilles Fakiris, MD Indianan University
  More Information

No publications provided by Indiana University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jill Deluca, Research Coordinator, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00246181     History of Changes
Other Study ID Numbers: 9910-35
Study First Received: October 27, 2005
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
Lung cancer
stereotactic body radiotherapy

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 July 22, 2014