High Dose Radiotherapy for Metastatic Cancer

Overseen By Sandy Chang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Disqualifiers: Hematologic malignancy, Intracranial disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore two types of radiotherapy for people with bulky metastatic cancer, focusing on their effectiveness and feasibility for symptom relief. Participants will receive either a standard dose or a slightly higher dose of radiation, applied directly to the tumor. This trial suits those diagnosed with solid tumors, having one to five large tumors over 5 cm in size, and who are not eligible for curative treatments.

As an unphased trial, it offers a unique opportunity to contribute to research that may improve symptom management for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that high-dose radiotherapy is generally safe for people with metastatic cancer. In one study, only 3.2% of patients experienced serious side effects. Another study found that using precise radiation to treat 10 or more cancer areas was safe, with manageable side effects.

Overall, these findings suggest that most patients tolerate high-dose radiotherapy well, making it a promising option for managing symptoms in advanced cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-dose radiotherapy (Hi-D) for metastatic cancer because it delivers a higher radiation dose of 27 Gy in 3 fractions with a boost. This approach could potentially offer better pain relief and shrink tumors more effectively than the current standard palliative radiotherapy, which typically uses a lower dose of 24 Gy in 3 fractions. By increasing the intensity of the radiation, Hi-D aims to improve the quality of life for patients by providing faster and more potent symptom relief.

What evidence suggests that this trial's treatments could be effective for metastatic cancer?

This trial will compare High-Dose Radiotherapy (Hi-D) with Standard Dose Palliative Radiotherapy for metastatic cancer. Research has shown that radiotherapy can help treat cancer that has spread to other parts of the body. In one study, 83% of patients responded well to radiotherapy, while only 3.2% experienced serious side effects. Another study found that combining radiotherapy with other treatments enhanced its effectiveness. However, some research suggests that high doses of radiation might cause untreated tumors to grow. Despite these concerns, radiotherapy has been shown to extend the period during which the cancer does not worsen in patients with metastatic cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Wei Liu, MD, FRCPC

Principal Investigator

BC Cancer - Vancouver

Are You a Good Fit for This Trial?

This trial is for individuals with bulky metastatic cancer who need palliative radiotherapy, specifically those with pancreatic cancer. Participants should be suitable for high-dose radiation treatment. The exact eligibility criteria are not provided, but typically include factors like overall health status and prior treatments.

Inclusion Criteria

I have 1 to 5 large tumors over 5cm in size.

Able to provide informed consent

I can care for myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

My condition is confined to my brain.

Pregnant women

I have a blood cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard 24 Gray in 3 fractions or high-dose 27 Gray in 3 fractions with dose escalation

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Assessed at 6 weeks, and months 3, 12, 18, 24

What Are the Treatments Tested in This Trial?

Interventions

• High Dose Radiotherapy for Palliation (Hi-D)

Trial Overview

The Hi-D trial is testing the effectiveness of two different doses of palliative radiotherapy in managing symptoms caused by metastatic cancer: a standard dose (24 Gray in 3 fractions) versus a higher dose (27 Gray in 3 fractions with targeted escalation). It's a single-blind study, meaning participants won't know which treatment they receive.

How Is the Trial Designed?

Group I: High-Dose RT Experimental Treatment 1 Intervention

27Gy in 3 fractions with boost

Group II: Standard Dose Palliative RT Active Control 1 Intervention

24Gy in 3 fractions

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Citations

1.

news.uchicago.edu

news.uchicago.edu/story/high-dose-radiation-therapy-may-fuel-cancer-spread-uchicago-study-finds

High dose radiation therapy may fuel cancer spread ...

A new study from the University of Chicago Medicine Comprehensive Cancer Center reveals that radiation therapy can spur growth in untreated metastatic tumors.

2.

uchicagomedicine.org

uchicagomedicine.org/forefront/cancer-articles/2025/may/study-reveals-surprising-side-effects-of-high-dose-radiation-therapy

Study reveals surprising side effects of high-dose radiation ...

Cancer researchers at UChicago Medicine find that high doses of radiation cause growth in existing metastatic tumors that weren't directly ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12130423/

Radiotherapy improves the clinical outcomes of recurrent or ...

We found that the group receiving immunotherapy combined with radiotherapy had higher objective response rate (67.6% vs 39.5%, p = 0.009) and ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S240563082300112X

Efficacy and safety analysis in metastatic cancer patients ...

Response to radiotherapy was observed in 548 (83.0 %) cases and CTCAE toxicity grade > 3 was observed in 21 (3.2 %) cases. •. An increasing number of RT courses ...

5.

mdanderson.org

mdanderson.org/newsroom/adding-metastasis-directed-radiation-therapy-boosts-progression-free-survival-in-metastatic-pancreatic-cancer.h00-159699912.html

radiation therapy boosts progression-free survival in ...

Approach achieves some of the longest progression-free survival times reported in a clinical trial for metastatic pancreatic cancer.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40926936/

Evaluating the Oncologic and Safety Outcomes of High ...

Our findings suggest that 30/5 may be a viable alternative palliative regimen for patients who require high-dose radiotherapy, but are not ...

7.

ecancer.org

ecancer.org/en/news/25972-study-shows-high-precision-radiation-therapy-is-safe-for-patients-with-cancer-that-has-spread-throughout-body

High-precision radiation safe for cancer spread

It was found to be safe in treating 10 or more lesions of cancer throughout the body. All results were within acceptable toxicity levels. “We ...

8.

cureus.com

cureus.com/articles/391851-evaluating-the-oncologic-and-safety-outcomes-of-high-dose-palliative-radiation-treatment-with-30-grays-in-five-fractions

Evaluating the Oncologic and Safety Outcomes of High ...

Higher biological equivalent doses of radiotherapy have been shown to improve symptom palliation and local control in select patient ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12414845/

Evaluating the Oncologic and Safety Outcomes of High-Dose ...

Higher biological equivalent doses of radiotherapy have been shown to improve symptom palliation and local control in select patient ...