N/A
N=44
Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung
Lung Cancer · Non Small Cell Lung Cancer · Solid Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00832780 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Response Rate (RR): — 38 tumors
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stereotactic Body Radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New Mexico Cancer Research Alliance
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (RR): |
38 | — |
| SECONDARY Treatment Related Toxicity |
4; 1; 7; 3; 1 | — |
| SECONDARY Overall Survival (OS) |
44 | — |
| SECONDARY Progression Free Survival (PFS) |
31 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
41 | — |
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 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.
Eligibility 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)
- 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
Data sourced from ClinicalTrials.gov (NCT00832780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.