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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00832780
First received: January 29, 2009
Last updated: February 25, 2014
Last verified: February 2014
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: INST 0810: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

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: 43
Study Start Date: January 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Body Radiation (SBRT)
60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days
Radiation: Stereotactic Body Radiation
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.
Other Name: SBRT

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:

  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
  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: NCT00832780

Locations
United States, New Mexico
Universtiy of New Mexico - Cancer Center
Albuquerque, New Mexico, United States, 87131-0001
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Ben Liem, M.D University of New Mexico Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00832780     History of Changes
Other Study ID Numbers: INST 0810, NCI-2011-02943
Study First Received: January 29, 2009
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:
Lung cancer
radiation therapy
SBRT
Stereotactic Body Radiation Therapy
Tomotherapy
other solid tumors

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 26, 2014