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

NCT02333110 | Unknown

• 1 other identifier: 14-161
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Symptom relief, as measured using the CTCAE grading system (v4.0) and pain questionnaire

  3 months post treatment

Secondary Outcomes (4)

• Acute toxicity of treatment, as measured using the CTCAE grading system (v4.0)

  1 week

• Long-term toxicity of treatment, as measured using the CTCAE grading system (v4.0)

  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

  3 months

• Tumor response, measured on CT-scan

  8 weeks

Study Arms (1)

GRID radiation therapy

EXPERIMENTAL

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

Radiation: spatially fractionated radiation therapy

Interventions

spatially fractionated radiation therapy RADIATION

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

Also known as: GRID radiation therapy

GRID radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Sir Mortimer Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Study Officials

• Te Vuong, MD

  Sir Mortimer Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Poggi, PhD

CONTACT

514-340-8222; luciana.poggi.trinidad.ccomtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Radiation-oncology department

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: January 7, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

CA (1)