Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to RadiationNCT02333110
GRID Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors
A study testing spatially fractionated radiation therapy in people with Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation
- What is being tested?
- spatially fractionated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Potentially curable patient
- Previous palliative radiation with hypofractionation
- Tumor located near the spinal cord or in the brain
- Pregnant or nursing woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sir Mortimer Jewish General Hospital
Montreal, Quebec, H3T 1E2
Harielle Lamarre, BSc, 514-340-8222 ext. 26199, hlamarre@jgh.mcgill.ca
About this study
Official title: Spatially Fractionated Radiation (SFR) Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors
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.
- Conditions
- Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation
- Being tested
- spatially fractionated radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spatially fractionated radiation therapyRadiation
Also called GRID radiation therapy
A single dose of 15-20Gys of spatially fractionated radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| GRID radiation therapy | Experimental | A single dose of 15-20Gys of spatially fractionated radiation therapy Receives: Radiation: spatially fractionated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire
Measured: 3 months post treatment
Secondary outcomes (4)
Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0)
Measured: 1 week
Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0)
Measured: 3, 6, 9, 12 months
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
Measured: 3 months
Tumor response, measured on CT-scan
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to RadiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Te Vuong, MD, Principal investigator, Sir Mortimer Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333110
- Sponsor's protocol ID
- 14-161
- Status last verified
- May 2026
- First submitted
- 22 Dec 2014
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatially Fractionated Radiation (SFR) Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors
- ClinicalTrials.gov ID
- NCT02333110
- Acronym / sponsor ID
- 14-161
- Conditions
- Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GRID radiation therapy | Experimental | Radiation: spatially fractionated radiation therapyA single dose of 15-20Gys of spatially fractionated radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Potentially curable patient
- Previous palliative radiation with hypofractionation
- Tumor located near the spinal cord or in the brain
- Pregnant or nursing woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spatially fractionated radiation therapyAlso: GRID radiation therapyA single dose of 15-20Gys of spatially fractionated radiation therapy | Radiation | GRID radiation therapy |
Primary outcome
Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire
Time frame: 3 months post treatment
4 secondary outcomes
Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0)
Time frame: 1 week
Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0)
Time frame: 3, 6, 9, 12 months
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
Tumor response, measured on CT-scan
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Te Vuong, MD principal investigator
Sir Mortimer Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spatially fractionated radiation therapy in people with Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luciana Poggi, PhD (514-340-8222 ext. 28443, luciana.poggi.trinidad.ccomtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire (time frame: 3 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.