Stereotactic Radiotherapy (SBRT) of Lung Metastasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Health Network, Toronto
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01803542
First received: August 10, 2010
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

The purpose of this institutional protocol is to offer SBRT to selected patients in a controlled environment to refine treatment techniques (including dose/fractionation schedules) and standardize follow-up. SBRT has been in clinical use for over a decade in some institutions and the available data suggest that it can be used safely and with good results. This study will see how effective Stereotactic Body Radiation Therapy is for treating tumours in the lung and how often people have side effects. Radiation therapy is usually given once a day, often for a few weeks. In this study, study participants will receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks.

Several reports indicate that this therapy might shrink tumours and control the cancer for extended periods of time. Although specialists started to treat patients with SBRT over 10 years ago, it is still used in relatively few cancer centres.


Condition Intervention Phase
Non-small Cell Lung Cancer
Metastasis From Other Cancers
Radiation: Stereotactic Radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lung Stereotactic Radiation Therapy for Patients With Non-small Cell Lung Cancer and Other Cancers

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Determine local control in patients treated with SBRT. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Determine pattern of relapse in patients treated with SBRT. [ Time Frame: 10 ] [ Designated as safety issue: No ]
  • Determine survival rates in patients treated with SBRT. [ Time Frame: 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize acute and late toxicity [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Assess the use of PET/CT in aiding target definition and predicting local response [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Assess the use of Cone Beam CT for precision imaging of the target and avoidance structures at each treatment [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Assess the use of 4D-computed tomography (CT) planning to determine Internal Treatment Volume (ITV) and Planning Treatment Volume (PTV) [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2006
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT
High dose of radiation will be used to treat tumours.
Radiation: Stereotactic Radiation
Participants will receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks.

Detailed Description:

SBRT is an adaptation of the principles and experience gained from stereotactic brain RT. SBRT was developed in the early 90s at the Karolinska Institute in Stockholm, Sweden, and is used as an accepted alternative of treatment for patients with early stage lung cancer in many centers in Japan and a number of centers in Germany,USA and elsewhere. It is also now being used for patients who have lung metastases and extra-thoracic disease (primary or metastatic). Many reports indicate excellent local control (80-90% or higher) and minimal toxicity in well selected patients treated with thoracic SBRT.

SBRT has traditionally had the following features:

  1. High doses of radiation, usually in a few large fractions (it is "hypofractionated" compared with standard radiotherapy schedules)
  2. Multiple radiation beams coming from different directions in the same plane ('co-planar' beams) as well as from different directions and different planes relative to the patient's body ('non-coplanar' beams)
  3. Stereotactic beam placement, in that it is guided by a set of coordinates These coordinates are defined in relationship to the precise location of the tumor, determined from medical imaging (e.g. CT, MRI), rather than to a set of external marks (tattoos) or anatomical landmarks (such as bony structures)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological confirmation of malignancy, unless the risks of biopsy are unacceptable and the lesion has grown on serial CT scan and/or is PET positive.
  • Eligible patients must have staging studies (e.g. chest radiograph, CT scan, MRI/CT Brain/Bone Scan) identifying them as:
  • patients with stage I or II, non-metastatic NSCLC (T1, N0, M0; T2 (≤ 5cm), N0, M0; or T3(≤ 5cm), N0, M0 chest wall primary tumors only)
  • patients with a non-lung primary that is controlled and which has metastasized to the lungs alone, in whom potentially curative surgery would otherwise be an option (e.g. colorectal, breast, sarcoma…etc)
  • the subset of patients with limited (low) volume metastatic NSCLC or other primary site tumors whom it is felt may derive benefit from highdose SBRT treatment to the primary or metastatic lung tumor. And in whom other sites of metastatic disease are being treated with the desire to achieve long term control. Lesions must meet size criteria in 4.1.2.1
  • Patients who have potentially resectable disease should be considered medically inoperable, or else in the judgement of the thoracic surgeon and lung team, surgery is not considered the preferred management option
  • Early stage lung cancer: ≤3 parenchymal lung lesions, Metastatic disease to lungs: ≤5 parenchymal lung lesions
  • Patients with early stage primary NSCLC should have hilar or mediastinal lymph nodes that are considered N0 on clinico-radiological grounds (i.e. no clinico-radiological evidence of lymph node spread)
  • In patients with early stage primary NSCLC and a co-existing malignancy, the co-existing malignancy must have an expected prognosis better than primary lung lesion
  • Adequate lung function to tolerate the planned stereotactic radiation
  • Previous conventional RT to mediastinum/lung allowed as long as SBRT is not expected to have a high probability of impairing lung function
  • Must be ≥ 18 years of age
  • Zubrod performance status must be between 0 and 3
  • Women of child bearing potential and male participants must use an effective contraceptive method
  • Willing and able to give informed consent

Exclusion Criteria:

  • Patients with active systemic, pulmonary or pericardial infection
  • No concurrent systemic therapy (chemotherapy, immunotherapy or biological therapy), apart from hormone therapy, is allowed
  • History of active auto-immune diseases, including systemic lupus erythematous, rheumatoid arthritis, C.R.E.S.T., systemic sclerosis,scleroderma
  • Potential candidate for concurrent chemo-radiation therapy
  • Patient enrollment on other studies may be permissible. This will depend on patient and study characteristics.
  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: NCT01803542

Contacts
Contact: John Cho, MD 416 946 2124 John.Cho@rmp.uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: John Cho, MD    416 946 2124    John.Cho@rmp.uhn.on.ca   
Principal Investigator: John Cho, MD         
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: John Cho, MD University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01803542     History of Changes
Other Study ID Numbers: UHN REB 05-0951-C
Study First Received: August 10, 2010
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Non-small Cell Lung Cancer
Stereotactic radiation for Lung Cancer
Cone beam CT for Lung Cancer
PET/CT for Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014