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

This study is currently recruiting participants.

Verified by University of New Mexico, July 2009

First Received: January 29, 2009 Last Updated: July 24, 2009 History of Changes

Sponsored by:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00832780

Purpose

The purpose of this study is to determine the response of lung tumors to radiation therapy. This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ. This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety.

Condition	Intervention	Phase
Lung Cancer Non Small Cell Lung Cancer Solid Tumors	Radiation: Stereotactic Body Radiation	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	INST 0810: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

The primary objective is to determine the response rate; complete response (CR) plus partial response (PR) of lung tumors to radiation therapy. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Intervention Details:

A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours.

Detailed Description:

same as above

Eligibility

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

Criteria

Inclusion Criteria:

Histologic confirmation of non small cell lung cancer or other solid primary tumor metastatic to lungs
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
Age greater than or equal to 18 years old
Zubrod performance status less than or equal to 1
Negative pregnancy test for women of child bearing potential
Informed consent
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.
No prior radiation to lesions being treated
For metastatic disease to lung, primary tumor needs to be controlled (no evidence of progression on imaging for at least 2 months).

Exclusion Criteria:

Contraindications to radiation
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]
Pregnant or lactating females who chose to breast feed
Patients must have recovered from toxicity of prior therapy
Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
Cytologically positive pleural effusion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832780

Contacts

Contact: Becky Myers-Brito

505-272-7843

RMyers-Brito@salud.unm.edu

Locations

United States, New Mexico
Universtiy of New Mexico - Cancer Center	Recruiting
Albuquerque, New Mexico, United States, 87131-0001
Principal Investigator: Ben Liem, M.D.

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:

Ben Liem, M.D

University of New Mexico

More Information

No publications provided

Responsible Party:	University of New Mexico - Cancer Center ( Ben Liem, M.D.; PI )
Study ID Numbers:	INST 0810
Study First Received:	January 29, 2009
Last Updated:	July 24, 2009
ClinicalTrials.gov Identifier:	NCT00832780 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of New Mexico:

Lung cancer
radiation therapy
SBRT

Stereotactic Body Radiation Therapy
Tomotherapy
other solid tumors

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 August 28, 2009