19 Participants NeededMy employer runs this trial

Radiosurgery for Cancer Pain

(FREEDOM Trial)

WD
CP
Overseen ByChristy Palodichuk
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Jonsson Comprehensive Cancer Center
Must be taking: Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage cancer pain unresponsive to standard treatments. It employs radiosurgery, a precise form of radiation therapy, to target specific brain areas involved in pain control. The researchers aim to determine if this approach can benefit individuals with severe cancer pain not alleviated by medications such as opioids. Those experiencing severe cancer pain despite strong painkillers may find this trial relevant. As an unphased trial, it presents a unique opportunity to investigate innovative pain management strategies that could enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves patients who have not achieved pain control with opioids, it might be possible to continue your current pain medications. Please consult with the trial team for specific guidance.

What prior data suggests that this radiosurgery technique is safe for treating cancer pain?

Research has shown that radiosurgery can be a safe option for patients with persistent cancer pain. In one study, patients experienced significant pain relief with few side effects. Another study found that this treatment reduced pain using low doses of radiation.

Safety data from 45 patients indicated that only six experienced side effects, with just five related to radiation. This suggests that most patients tolerate the treatment well. Radiosurgery targets abnormal tissue while sparing healthy tissue, which may explain its safety.

Overall, current evidence suggests that radiosurgery is generally well-tolerated and effectively reduces pain with minimal side effects.12345

Why are researchers excited about this trial?

Unlike the standard treatments for cancer pain, which often involve medications like opioids or traditional radiation therapy, this new radiosurgery technique focuses on precision. Researchers are excited because it uses intracranial functional stereotactic radiosurgery (FnSRS) to target specific brain areas linked to pain, namely the centromedian-parafasciular complex and the hypophysis. This precise targeting could mean more effective pain relief with potentially fewer side effects, offering a promising alternative to current pain management strategies.

What evidence suggests that radiosurgery might be an effective treatment for cancer pain?

Research shows that radiosurgery, the treatment under study in this trial, can significantly relieve pain for cancer patients. Studies have found that this precise radiation therapy offers better chances of complete pain relief compared to traditional methods. In some cases, up to 93.5% of patients experience pain relief within weeks of treatment. Other studies indicate that at least 35% of patients enjoy long-lasting pain relief. Radiosurgery uses targeted, high-dose radiation to focus on specific areas, which can help reduce pain when other treatments haven't worked. While results can vary, these findings suggest promising outcomes for managing cancer-related pain.678910

Are You a Good Fit for This Trial?

This trial is for people with cancer who have severe pain that hasn't improved with strong painkillers or other treatments. Participants must be medically stable enough to undergo radiosurgery and will be evaluated by a team of specialists.

Inclusion Criteria

Written informed consent (and assent when applicable) obtained from patient or patient's legal representative and ability for patient to comply with the study requirements and agree to undergo the study's SRS treatment plan
I am 18 years old or older.
My cancer pain is severe and not controlled by my current opioid medications.
See 1 more

Exclusion Criteria

I have claustrophobia or cannot lie flat.
Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive intracranial functional stereotactic radiosurgery (FnSRS) to the centromedian-parafascicular complex bilaterally, and the hypophysis

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of opioid usage, pain anxiety, depression, and quality of life

4 weeks
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Radiosurgery

Trial Overview

The study tests whether targeted radiosurgery to specific brain areas (pituitary gland and parts of the thalamus) can help relieve hard-to-treat cancer-related pain. Patients receive one high-dose treatment using advanced radiation techniques.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

Brainlab AG

Industry Sponsor

Trials
6
Recruited
590+

Citations

Personalized Radiation Therapy in Cancer Pain Management

Response to re-irradiation with conventional radiation therapy, however, was modest, with overall response rates of 45–52% and complete pain relief experienced ...

Comparative Analysis of Stereotactic Radiation Therapy ...

Stereotactic radiation therapy (SRT) has improved in achieving complete pain relief while exhibiting a decreased probability of delivering stationary pain.

Cancer Pain: Radiotherapy as a Double-Edged Sword

RT provides relief for 60–80% of patients by reducing tumor size and mitigating associated pain. Radiotherapy itself can also induce pain.

Radiosurgery for Chronic Pain

Effectiveness Not Established. Radiosurgery utilizes externally generated radiation beams that are precisely focused to deliver high doses to a target area.

Study Shows CyberKnife® System Provides Long-Lasting ...

Pain relief was achieved in 93.5 percent of patients after a median delay of three weeks after treatment · 78.9 percent of patients were ...

Stereotactic Radiosurgery Hypophysectomy for Palliative ...

Stereotactic radiosurgery hypophysectomy offers significant pain relief with minimal side effects for patients suffering from refractory cancer pain.

Triple-target radiosurgery for intractable cancer pain of mixed ...

Our findings indicate that a minimally invasive triple-target method, utilising low radiation doses, effectively alleviates pain, lowers ...

Stereotactic Radiosurgery Hypophysectomy for Palliative ...

This review highlights the role of hypophysectomy in alleviating advanced cancer pain, both in hormonal and nonhormonal malignancy and the current mechanistic ...

Stereotactic Radiosurgery in Reducing Pain ...

This trial studies how well stereotactic radiosurgery works in reducing pain in patients with cancer that has spread to the bone. Stereotactic radiosurgery ...

Stereotactic Radiosurgery Versus Radiofrequency Ablation ...

The objective of this study is to evaluate the efficacy and safety of stereotactic radiotherapy and radiofrequency ablation as treatment options for such ...