Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable NSCLC or Metastatic Lung Tumours

Study Overview
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Brief Summary
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Medically inoperable lung cancer or metastatic lung tumours will be treated with fractionated stereotactic radiation using a schedule of 1) 12 Gy x 4 treatments or 2) 6 Gy x 10 treatments.

Detailed Description
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You will be positioned in a special body mould while you are lying in the treatment position. This ensures that you are treated in the exact position each time. A soft plastic sheet may be placed over your body from the chest down. A vacuum device may be used to apply the sheet gently over you. This mild compression will ensure that you can breathe comfortably but will minimize any movement which may affect the accuracy of your treatments. A CT (computed tomography) scan will be done for your treatment planning. The CT scan will take approximately 45 minutes. In some cases, intravenous dye may be administered during the CT scan. You will be asked to hold your breath for a short time during the CT scan. If you are unable to hold your breath comfortably, the scan will be performed during your normal breathing cycle. In some cases, your doctor may also order a PET (positron emission tomography) scan. The treatment planning to be done by your oncologist and physicist will take approximately one to two weeks. After that is completed, your treatments will begin. Each treatment will take about 30 minutes. If the CT scans show that there is a lot of movement of your lung cancer due to breathing motion, your oncologist may recommend the insertion of a fiducial marker to help guide your treatments. An additional consent form will be obtained prior to this procedure. The fiducial marker is a tiny gold or stainless steel coil measuring about one inch long. It would be inserted into your lung in or next to the tumour by a respirologist via bronchoscopy under sedation. The procedure would take approximately 30 minutes, and you would be in hospital for about 4 hours. You would meet the respirologist in the clinic in consultation prior to the procedure so that he/she can tell you more about the procedure and assess your case in details to determine if it is safe for you to undergo the procedure. The insertion of the fiducial marker is considered part of your clinical care and a separate consent will be required prior to this procedure. You may choose not to undergo this procedure but still participate in this study. In some cases, your respirologist may have already inserted a fiducial marker at the time of diagnostic bronchoscopy after discussions with yourself and your radiation oncologist. The fiducial marker would be used to guide your radiation treatments during your normal breathing cycle. You will be assigned into one of the two study groups described below depending on the location of your tumour: Schedule I (10 fractions): You will receive a total of 10 stereotactic radiation treatments, given over 3 weeks. Schedule II (4 fractions): You will receive a total of 4 stereotactic radiation treatments, given over 2 weeks.

Official Title
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Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Non-Small Cell Lung Cancer (NSCLC) or Metastatic Lung Tumours

Conditions
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Lung Neoplasms, Lung Cancer

Intervention / Treatment
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* Procedure: Fractionated Stereotactic Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-small cell lung cancer less than 6cm; no mediastinal or distant metastases Open to Alberta,Canada Residents Exclusion Criteria: tumour size greater than 6cm; inadequate pulmonary function(ie. FEV1 less than 0.8 L), Karnofsky performance status less than 70, multiple co-morbid conditions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Schedule I (10 fractions)<br>Subjects will receive a total of 10 stereotactic radiation treatments, given over 3 weeks. | Procedure: Fractionated Stereotactic Radiotherapy<br> <br> |
| Experimental: Schedule II (4 fractions)<br>Subjects will receive a total of 4 stereotactic radiation treatments, given over 2 weeks. | Procedure: Fractionated Stereotactic Radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity as defined by CTCAE V3 grade 4 or 5. | Each schedule will be evaluated according to the occurrence of DLTs observed. | At the completion of accrual, an analysis with respect to acute toxicity will be performed after all patients have been followed a minimum of 90 days from the start of RT. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung neoplasms, metastatic lung cancer, stereotactic radiation