Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung
This study is currently recruiting participants.
Verified March 2013 by New Mexico Cancer Care Alliance
Sponsor:
New Mexico Cancer Care Alliance
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00832780
First received: January 29, 2009
Last updated: March 15, 2013
Last verified: March 2013
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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: | November 2015 |
| Estimated Primary Completion Date: | November 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:
- 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: Valerie Parks, BSN | 505-925-0390 | vparks@salud.unm.edu |
Locations
| United States, New Mexico | |
| Universtiy of New Mexico - Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-0001 | |
| Contact: Valerie Parks, BSN 505-925-0390 vparks@salud.unm.edu | |
| Principal Investigator: Ben Liem, M.D. | |
| Memorial Medical Center | Withdrawn |
| Las Cruces, New Mexico, United States, 88011 | |
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
| Principal Investigator: | Ben Liem, M.D | University of New Mexico Cancer Center |
More 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: | March 15, 2013 |
| 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 May 23, 2013