Radiotherapy for Cancer-Related Pain

Recruiting at 5 trial locations

Overseen By Wendy Parulekar

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Canadian Cancer Trials Group

Must not be taking: Radionuclide therapy, Chemotherapy

Disqualifiers: Metastases in hands, feet, cranium, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Stereotactic Body Radiation Therapy (SBRT) eases cancer-related pain more effectively than Conventional Radiation Therapy (CRT). SBRT targets high doses of radiation on the painful cancer area while protecting nearby healthy tissues, unlike CRT, which might affect them. Individuals with solid tumors and a significant painful bone area (excluding the spine, hands, feet, or head) may be suitable candidates. Participants should have stable pain and an expected lifespan of more than six months. The trial aims to determine which treatment provides better pain relief. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer pain management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that your pain should be stable with no immediate plan to change your pain medication routine.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Stereotactic Body Radiotherapy (SBRT), a treatment for painful cancer spread to bones, is generally safe and well-tolerated. One study found that 87.7% of patients experienced partial to complete pain relief three months after receiving SBRT, indicating its effectiveness in managing pain.

Another review found that SBRT and conventional External Beam Radiotherapy (cEBRT) had similar pain relief outcomes, suggesting that SBRT is equally safe. Additionally, SBRT provides long-lasting pain control without major side effects.

These findings suggest that SBRT is a promising option for managing cancer-related pain, with a good safety record and effective pain relief. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer-related pain?

Stereotactic Body Radiotherapy (SBRT) is unique because it delivers high doses of radiation with pinpoint precision to cancer-related pain sites, minimizing damage to nearby healthy tissues. Unlike traditional radiotherapy, which often requires multiple sessions over several weeks, SBRT can be completed in fewer sessions, potentially reducing overall treatment time and improving patient convenience. Researchers are excited about SBRT because its targeted approach could lead to faster pain relief and better quality of life for patients suffering from cancer-related pain.

What evidence suggests that this trial's treatments could be effective for cancer-related pain?

This trial will compare Stereotactic Body Radiotherapy (SBRT) with Standard Conventional Radiotherapy for cancer-related pain. Research has shown that SBRT can relieve pain in cancer patients more effectively than traditional radiation therapy. One study found that SBRT provided complete pain relief in more cases than conventional radiation, with better results at different times. Specifically, about 57.6% of patients experienced significant pain relief within three months with SBRT. This method targets high doses of radiation at the painful area while protecting healthy tissue, which may lead to better long-term pain control. Although not all studies agree on the overall pain response, SBRT often results in more complete pain relief compared to traditional methods. ^{4 6 7 8 9}

Who Is on the Research Team?

Arjun Sahgal

Principal Investigator

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

Tim Nguyen

Principal Investigator

London Regional Cancer Program, London, ON, Canada

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10862159/

Stereotactic Body and Conventional Radiotherapy for ... The ITT meta-analysis showed that SBRT achieved a higher complete pain response than cEBRT after 1 (RR, 1.43; 95% CI, 1.02-2.01), 3 (RR, 1.80; ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0167814023898085/pdf

Systematic Review Stereotactic body radiation therapy ... SBRT does not provide better overall pain response compared to cEBRT. •. Complete pain response may be better with SBRT compared to cEBRT. •. Spine SBRT ...

3. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/41/4/article-p532.xml

Stereotactic body radiotherapy for painful spinal metastases The key finding demonstrates that SBRT achieved significant pain relief in 57.6% of lesions within 3 months. This study adds value by ...

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)89863-2/fulltext

Efficacy and safety of SBRT for spine metastases Globally, despite the heterogeneity of the data derived from these randomized studies, SBRT resulted in improved long-term pain control and it ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4733601/

Prognostic factors associated with pain palliation after ... Stereotactic radiosurgery has effectively achieved local control and symptomatic relief for these patients. The authors determined prognostic factors that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9627033/

Efficacy and safety of stereotactic body radiotherapy for painful ... This study shows that for painful bone metastases, patients with SBRT experienced better pain relief 3 months after radiation than patients with cRT.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814927

Stereotactic Body and Conventional Radiotherapy for ... In this systematic review and meta-analysis, patients with painful bone metastases experienced similar overall pain response after SBRT compared with cEBRT.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301624000245

Clinical Outcomes After Stereotactic Body Radiation ... The estimated 3-month combined partial and complete pain response rate after SBRT was 87.7% (95% CI, 55.1%-100.0%). The estimated combined acute and late grade ...

9. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35310

Dose‐intensified stereotactic body radiotherapy for painful ... Early studies on SBRT for painful vertebral metastases demonstrated durable pain relief in 80%–90% of patients, with lower retreatment rates and ...