Back to resultsStereotactic Body Radiation Therapy in Stage II/III Non Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Boost Stereotactic Body Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histological confirmation of non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchoalveolar cell carcinoma, or non-small cell carcinoma NOS) by either biopsy or cytology.
- Clinical AJCC stage IIA (T1N1M0), IIB (T2,N1M0, T3,N0,M0) or IIIA (T1-3, N1-2,M0)/selected IIIB. In all cases, patients may be included at the discretion of the treating radiation oncologist if it will be likely the disease can be encompassed by the stereotactic boost will be included.
- Patients with non-bulky (< 2.0-3.0 cm) hilar or mediastinal lymphadenopathy determined by pre-treatment CT scan, PET or mediastinoscopy
- Must have completed a standard course of chemoradiation in accordance with NCCN Guidelines
- One month following definitive chemoradiation, CT or PET-CT revealing limited volume residual disease within the site of primary tumour mass (post-chemo/RT mass </= 7.0 cm). Patients with a CR and no obvious target are not eligible.
- must be able to fit into the Elekta Stereotactic body frame
- Patients must be ≥ 18 years of age.
- The patient's ECOG performance status must be 0-2.
- Women of childbearing potential and male participants must use an effective contraceptive method.
- Patients must sign a study-specific consent form.
Exclusion Criteria:
- Any other active cancer OR No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the patient has been disease-free for 5 years.
- Patients with other systemic illness, or have not recovered adequately from their primary treatment or who have evidence of progression of their lung cancer prior to therapy that, in the investigators opinions, would preclude their inclusion
- Plans for the patient to receive other concomitant antineoplastic therapy while on this protocol, except at disease progression. Patients may be allowed to use bisphosphonates for hypercalcemia.
- Pregnant or lactating women
Sites / Locations
- Markey Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiation Therapy
Arm Description
Boost Stereotactic Body Radiation Therapy (SBRT)
Outcomes
Primary Outcome Measures
Boost Dose Toxicity
Pneumonitis will be used as a marker of lung toxicity as a result of the Boost treatment. Participants will follow up with their treating physician annually for five years after treatment with SBRT . Any incidence of pneumonitis will be documented. Data will be presented as the percent of subjects receiving SBRT that required treatment for pneumonitis.
Secondary Outcome Measures
Primary Tumor Relapse Following SBRT
The response rates of the residual primary tumor following SBRT boost will be determined using a modified version of the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Data will be presented as the percent of participants with recurrence of the primary tumor after extended follow up, up to 5 years.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01657617
Brief Title
Stereotactic Body Radiation Therapy in Stage II/III Non Small Cell Lung Cancer
Official Title
Stereotactic Body Radiation Therapy for Post-chemoradiation Residual Disease in Stage II/III Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2007 (Actual)
Primary Completion Date
June 5, 2014 (Actual)
Study Completion Date
July 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ronald McGarry
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It is apparent that local control for Non-small Cell Lung Cancer (NSCLC) remains a significant problem. Conventional radiation therapy techniques have limitations for the dose that can be delivered to a chest tumor mass due to the adjacent dose limiting organs. Mounting evidence supports the use of hypofractionated stereotactically delivered radiation therapy to control lung cancer with acceptable toxicity profiles.
Thus the investigators propose to increase the doses of radiation to residual masses of NSCL to a BED > 100 Gy by the addition of two fractions of stereotactically delivered boost radiation therapy to residual disease post-conventional chemoradiation to at least 59.4 Gy in 180 cGy fractions. Using the linear quadratic equation to model doses of radiation therapy, 59.4 Gy would have a BED of approximately 70 Gy. Single fraction stereotactic body radiation therapy (SBRT) of 10 Gy would have a BED of approximately 20 Gy. Thus the addition of two fractions of 10Gy of SBRT to limited volumes of PET residual disease would theoretically result in higher degrees of local control of lung cancer masses, achieving a minimum cumulative BED of approximately 110Gy-equivalent.
Detailed Description
Lung cancer represents one of the most challenging malignancies to manage. Cure rates have only marginally improved in the last 20 years. It is the most commonly fatal cancer in both men and women with overall 5 year survivals of 15%. Lung cancer kills more Americans than the next three most common malignancies combined.
Most non small cell lung cancer (NSCLC) presents at advanced stages. Only approximately 25% present with stage I/II disease, 40% with stage III and 35% patients present with stage IV. (1) The optimal treatment of stage II/III NSCLC is complex. For those patients who are surgical candidates and a complete resection is technically feasible, radical surgery remains the standard of care. Traditionally, those patients with multiple N2 nodal levels or T4 disease are considered inoperable. Given that the average age of patients diagnosed with NSCLC is in their mid-60's and usually have long smoking histories, many patients are medically inoperable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiation Therapy
Arm Type
Experimental
Arm Description
Boost Stereotactic Body Radiation Therapy (SBRT)
Intervention Type
Radiation
Intervention Name(s)
Boost Stereotactic Body Radiation Therapy
Intervention Description
The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:
Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.
Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy.
Primary Outcome Measure Information:
Title
Boost Dose Toxicity
Description
Pneumonitis will be used as a marker of lung toxicity as a result of the Boost treatment. Participants will follow up with their treating physician annually for five years after treatment with SBRT . Any incidence of pneumonitis will be documented. Data will be presented as the percent of subjects receiving SBRT that required treatment for pneumonitis.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Primary Tumor Relapse Following SBRT
Description
The response rates of the residual primary tumor following SBRT boost will be determined using a modified version of the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Data will be presented as the percent of participants with recurrence of the primary tumor after extended follow up, up to 5 years.
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological confirmation of non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchoalveolar cell carcinoma, or non-small cell carcinoma NOS) by either biopsy or cytology.
Clinical AJCC stage IIA (T1N1M0), IIB (T2,N1M0, T3,N0,M0) or IIIA (T1-3, N1-2,M0)/selected IIIB. In all cases, patients may be included at the discretion of the treating radiation oncologist if it will be likely the disease can be encompassed by the stereotactic boost will be included.
Patients with non-bulky (< 2.0-3.0 cm) hilar or mediastinal lymphadenopathy determined by pre-treatment CT scan, PET or mediastinoscopy
Must have completed a standard course of chemoradiation in accordance with NCCN Guidelines
One month following definitive chemoradiation, CT or PET-CT revealing limited volume residual disease within the site of primary tumour mass (post-chemo/RT mass </= 7.0 cm). Patients with a CR and no obvious target are not eligible.
must be able to fit into the Elekta Stereotactic body frame
Patients must be ≥ 18 years of age.
The patient's ECOG performance status must be 0-2.
Women of childbearing potential and male participants must use an effective contraceptive method.
Patients must sign a study-specific consent form.
Exclusion Criteria:
Any other active cancer OR No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the patient has been disease-free for 5 years.
Patients with other systemic illness, or have not recovered adequately from their primary treatment or who have evidence of progression of their lung cancer prior to therapy that, in the investigators opinions, would preclude their inclusion
Plans for the patient to receive other concomitant antineoplastic therapy while on this protocol, except at disease progression. Patients may be allowed to use bisphosphonates for hypercalcemia.
Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald C. McGarry, MD, PhD.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Stereotactic Body Radiation Therapy in Stage II/III Non Small Cell Lung Cancer
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