Radiotherapy for Cancer-Related Pain

Recruiting at 2 trial locations

Overseen By Wendy Parulekar

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Canadian Cancer Trials Group

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 week

230 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to answer the following question: Is Stereotactic Body Radiation Therapy or SBRT (a form of radiation therapy which can deliver high doses of radiation to the specific painful area of the body most affected by cancer, while keeping the radiation beams away from the healthy parts of the body that surround the cancer) better for pain relief than the standard treatment of conventional radiation therapy or CRT (a form of radiation therapy which delivers radiation to the painful area but can also negatively affect other parts of the body in the same area)

Research Team

Tim Nguyen

Principal Investigator

London Regional Cancer Program, London, ON, Canada

Arjun Sahgal

Principal Investigator

Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

Eligibility Criteria

This trial is for cancer patients with a life expectancy over 6 months, confirmed solid tumor diagnosis, and significant pain from non-spine bone metastasis. They should be able to undergo both SBRT and CRT treatments without changing their current pain medications and have an ECOG performance status of 0-2.

Inclusion Criteria

Histologic confirmation of solid tumour

Expected overall survival of greater than 6 months as determined by the treating physician

I am eligible for specific radiation therapy as per the study.

Exclusion Criteria

My cancer has spread to my hands, feet, skull, or spine.

Pregnant or lactating individuals

My cancer that started in the bones comes from small cell or germ cell.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Stereotactic Body Radiotherapy (SBRT) or Conventional Palliative Radiotherapy (CRT) for 5 treatments

1 week

5 visits (in-person)

Follow-up

Participants are monitored for pain response and radiological progression

6 months

2 visits (in-person) at 3 and 6 months post-treatment

Treatment Details

Interventions

• Standard Conventional Radiotherapy
• Stereotactic Body Radiotherapy

Trial Overview The study compares two types of radiation therapy: Stereotactic Body Radiation Therapy (SBRT), which targets high doses directly at the cancerous area while sparing healthy tissue, versus Conventional Radiation Therapy (CRT), which affects a broader area.

Participant Groups

Group I: Stereotactic Body Radiotherapy Experimental Treatment 1 Intervention

Group II: Standard Conventional Radiotherapy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+