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Stereotactic Body Radiation Therapy for Post-chemoradiation Residual Disease in Stage II/III Non-small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Stereotactic Body Radiation Therapy for Post-chemoradiation Residual Disease in Stage II/III Non-small Cell Lung Cancer

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.

Inclusion Criteria:

1. 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.

2. 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.

3. Patients with non-bulky (< 2.0-3.0 cm) hilar or mediastinal lymphadenopathy
determined by pre-treatment CT scan, PET or mediastinoscopy

4. Must have completed a standard course of chemoradiation in accordance with NCCN

5. 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 cm). Patients with a CR and no obvious target are not eligible.

6. must be able to fit into the Elekta Stereotactic body frame

7. Patients must be ≥ 18 years of age.

8. The patient's ECOG performance status must be 0-2.

9. Women of childbearing potential and male participants must use an effective
contraceptive method.

10. Patients must sign a study-specific consent form.

Exclusion Criteria:

1. 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.

2. 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

3. 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.

4. Pregnant or lactating women

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the toxicity of the SBRT boost dose by estimating the proportion of subjects enrolled who develop pneumonitis

Outcome Time Frame:

30 days post SBRT

Safety Issue:


Principal Investigator

Ronald C. McGarry, MD, PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kentucky


United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

December 2015

Related Keywords:

  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Markey Cancer Center Lexington, Kentucky  40536