Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

GRID Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02333110
Recruitment Status : Recruiting
First Posted : January 7, 2015
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital

Brief Summary:
Palliative radiation therapy represents 40% of the on-going radiation at the Jewish General Hospital. In a traditional palliative radiation treatment to bulky or radioresistant tumors, radiotherapy schema varies from 24 to 30 Gys given in 3 to 10 fractions, depending on the tumor size, tumor location and tumor pathology. However, for many patients this treatment involves considerable toxicity, travel and time spent at the hospital. Spatially fractionated radiation (SFR) is an alternative technique that consists in delivering one single treatment, given through a grid containing holes. The present study is proposing to validate SFR as a safe and effective mean to palliate patients with symptomatic bulky tumors (more than 8 cm) or with tumors known to be resistant to radiation.

Condition or disease Intervention/treatment Phase
Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation Radiation: spatially fractionated radiation therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Spatially Fractionated Radiation (SFR) Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors
Study Start Date : January 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: GRID radiation therapy
A single dose of 15-20Gys of spatially fractionated radiation therapy
Radiation: spatially fractionated radiation therapy
A single dose of 15-20Gys of spatially fractionated radiation therapy
Other Name: GRID radiation therapy




Primary Outcome Measures :
  1. Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire [ Time Frame: 3 months post treatment ]

Secondary Outcome Measures :
  1. Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0) [ Time Frame: 1 week ]
  2. Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0) [ Time Frame: 3, 6, 9, 12 months ]
  3. Cost-effectiveness, as measured by evaluating the cost of the procedure per patient and the efficacy of treatment with regards to symptom relief and tumor response [ Time Frame: 3 months ]
  4. Tumor response, measured on CT-scan [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with histologically or cytologically confirmed malignancy. All malignant histologies/cytologies are eligible.
  • Patient with bulky tumor (larger than 8cm), or with a tumor known to be resistant to radiation (eg. Melanoma, hypernephroma, sarcoma), or with a tumor previously irradiated with a palliative intent requiring more than 1 fraction of radiation
  • Patient planned to undergo palliative radiation therapy treatments to one of the following 5 sites: extremities, neck, chest, abdomen and pelvis
  • WHO performance status of 0-2
  • Aged 18 years or older
  • Ability to sign and understand an informed consent form

Exclusion Criteria:

  • Potentially curable patient
  • Previous palliative radiation with hypofractionation
  • Tumor located near the spinal cord or in the brain
  • Pregnant or nursing woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333110


Contacts
Layout table for location contacts
Contact: Luciana Poggi, PhD 514-340-8222 ext 28443 luciana.poggi.trinidad.ccomtl@ssss.gouv.qc.ca

Locations
Layout table for location information
Canada, Quebec
Sir Mortimer Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Harielle Lamarre, BSc    514-340-8222 ext 26199    hlamarre@jgh.mcgill.ca   
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Te Vuong, MD Sir Mortimer Jewish General Hospital
Layout table for additonal information
Responsible Party: Dr. Te Vuong, Director, Radiation-oncology department, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT02333110    
Other Study ID Numbers: 14-161
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms