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INST 0810: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

Phase 2
18 Years
Open (Enrolling)
Lung Cancer, Non Small Cell Lung Cancer, Solid Tumors

Thank you

Trial Information

INST 0810: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

same as above

Inclusion Criteria:

1. Histologic confirmation of non small cell lung cancer or other solid primary tumor
metastatic to lungs

2. Medically inoperable stage I or II non small cell lung cancer with negative lymph
nodes or metastatic cancer to lung with less than or equal to 3 lesions

3. Age greater than or equal to 18 years old

4. Zubrod performance status less than or equal to 1

5. Negative pregnancy test for women of child bearing potential

6. Informed consent

7. Each lesion must be less than or equal to 5 cm in maximal diameter and multiple
lesions must be less than or equal to 18 cm for the sum of the diameters in 3
dimensions. Example: 3 lesions each 2+2+2 cm have an aggregate diameter of 18 cm
which is acceptable.

8. No prior radiation to lesions being treated

9. For metastatic disease to lung, primary tumor needs to be controlled (no evidence of
progression on imaging for at least 2 months).

Exclusion Criteria:

1. Contraindications to radiation

2. Within or touching the zone of proximal bronchial tree defined as a volume 2 cm in
all directions around the proximal bronchial tree (carina, right and left main
bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe
bronchus, lingular bronchus, right and left lower lobe bronchi) [SEE APPENDIX I]

3. Pregnant or lactating females who chose to breast feed

4. Patients must have recovered from toxicity of prior therapy

5. Any co morbid condition that' in the view of the attending physician' renders the
patient at high risk from treatment complications

6. Cytologically positive pleural effusion

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective is to determine the response rate; complete response (CR) plus partial response (PR) of lung tumors to radiation therapy.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Ben Liem, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center


United States: Institutional Review Board

Study ID:

INST 0810



Start Date:

January 2008

Completion Date:

November 2015

Related Keywords:

  • Lung Cancer
  • Non Small Cell Lung Cancer
  • Solid Tumors
  • Lung cancer
  • radiation therapy
  • SBRT
  • Stereotactic Body Radiation Therapy
  • Tomotherapy
  • other solid tumors
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Universtiy of New Mexico - Cancer CenterAlbuquerque, New Mexico  87106
Memorial Medical CenterLas Cruces, New Mexico  88011