Clinical trial NCT00832780: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung
Official title: INST 0810: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Non Small Cell Lung Cancer
Solid Tumors
Keywords: Lung cancer
radiation therapy
SBRT
Stereotactic Body Radiation Therapy
Tomotherapy
other solid tumors
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2009-01-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 survival and local control for tumors of the lung, including cancer that originates in the lung (such as non-small cell lung cancer) as well as cancer that metastasizes to the lung.

The purpose of this study is to determine the response rate and toxicity of SBRT treatment of patients with lung tumors. This study will use a dose of 60 gray (Gy) in 5 fractions of 12 Gy. This provides a biological equivalent dose with alpha/beta ratio of 10 (BED10) of 132 Gy with the anticipation of achieving local control without increased toxicity. Previous studies have shown that the response rate with SBRT across multiple studies is approximately 50%, with an additional 25-40% of patients having stable disease. We hypothesize that this regimen will achieve a response rate of 70% with grade 3 toxicity of less than 5%.

Eligibility 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)
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

Primary outcomes:
measure: Response Rate (RR):
timeFrame: 2 years
Secondary outcomes:
measure: Treatment Related Toxicity
timeFrame: 2 years
measure: Overall Survival (OS)
timeFrame: up to 67 months
measure: Progression Free Survival (PFS)
timeFrame: 2 years
measure: Clinical Benefit Rate (CBR)
timeFrame: 2 years
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Universtiy of New Mexico Comprehensive Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico Comprehensive Cancer Center
name: Ben Liem, M.D
role: PRINCIPAL_INVESTIGATOR
References: