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

NCT ID: NCT02333110

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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GRID radiation therapy

A single dose of 15-20Gys of spatially fractionated radiation therapy

Group Type EXPERIMENTAL

spatially fractionated radiation therapy

Intervention Type RADIATION

A single dose of 15-20Gys of spatially fractionated radiation therapy

Interventions

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spatially fractionated radiation therapy

A single dose of 15-20Gys of spatially fractionated radiation therapy

Intervention Type RADIATION

Other Intervention Names

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GRID radiation therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Te Vuong

Director, Radiation-oncology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Te Vuong, MD

Role: PRINCIPAL_INVESTIGATOR

Sir Mortimer Jewish General Hospital

Locations

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Sir Mortimer Jewish General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Luciana Poggi, PhD

Role: CONTACT

514-340-8222 ext. 28443

Facility Contacts

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Harielle Lamarre, BSc

Role: primary

514-340-8222 ext. 26199

Other Identifiers

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14-161

Identifier Type: -

Identifier Source: org_study_id

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