Status:
COMPLETED
Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung
Lead Sponsor:
New Mexico Cancer Research Alliance
Conditions:
Lung Cancer
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 kin...
Detailed Description
The introduction of stereotactic body radiation therapy (SBRT) has allowed safe dose escalation in treatment regimens for cancer. Several studies have shown a radiation dose-response relationship for ...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00832780
Start Date
January 1 2008
End Date
December 1 2018
Last Update
May 21 2021
Active Locations (1)
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1
Universtiy of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87131-0001