CompletedNot applicableNCT00832780
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic Body Radiation

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 21, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?New Mexico Cancer Research Alliance

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
New Mexico Cancer Research Alliance
Interventions being studied
Radiation: Stereotactic Body Radiation
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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).

Reasons someone may not be able to joinExclusion 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) 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Universtiy of New Mexico Comprehensive Cancer CenterAlbuquerque, New Mexico

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 21, 2021. Always confirm current availability with the study team.

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