Viewing Study NCT00351962



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Last Modification Date: 2024-10-26 @ 9:26 AM
Study NCT ID: NCT00351962
Status: COMPLETED
Last Update Posted: 2017-09-21
First Post: 2006-07-11

Brief Title: Phase III Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable NSCLC or Metastatic Lung Tumours
Sponsor: AHS Cancer Control Alberta
Organization: AHS Cancer Control Alberta

Study Overview

Official Title: Phase III Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Non-Small Cell Lung Cancer NSCLC or Metastatic Lung Tumours
Status: COMPLETED
Status Verified Date: 2013-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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: 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 heshe 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None