This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00351962
First received: July 11, 2006
Last updated: September 20, 2017
Last verified: July 2013
  Purpose
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.

Condition Intervention
Lung Neoplasms Lung Cancer Procedure: Fractionated Stereotactic Radiotherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Non-Small Cell Lung Cancer (NSCLC) or Metastatic Lung Tumours

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Dose-limiting toxicity as defined by CTCAE V3 grade 4 or 5. [ Time Frame: 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. ]
    Each schedule will be evaluated according to the occurrence of DLTs observed.


Enrollment: 58
Actual Study Start Date: September 2006
Study Completion Date: July 2, 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Schedule I (10 fractions)
Subjects will receive a total of 10 stereotactic radiation treatments, given over 3 weeks.
Procedure: Fractionated Stereotactic Radiotherapy
Experimental: Schedule II (4 fractions)
Subjects will receive a total of 4 stereotactic radiation treatments, given over 2 weeks.
Procedure: Fractionated Stereotactic Radiotherapy

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351962

Locations
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Harold P Lau, MD Tom Baker Cancer Center
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00351962     History of Changes
Other Study ID Numbers: 20131
Study First Received: July 11, 2006
Last Updated: September 20, 2017

Keywords provided by AHS Cancer Control Alberta:
lung neoplasms
metastatic lung cancer
stereotactic radiation

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 21, 2017