Radiation Therapy for Bone Metastases

Overseen By Quynh Nguyen, M D

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Radioactive isotopes

Disqualifiers: Prior radiation, Cord compression, Fracture, Metastases to hand/feet, 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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1-5 days

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how different doses and schedules of stereotactic body radiation therapy (SBRT) affect individuals with cancer that has spread to their bones. Researchers aim to determine if altering the treatment can better manage pain and improve quality of life compared to the usual treatment schedule. Participants will receive either a standard dose over a few days or a higher dose over a different set of days. Individuals with bone metastases experiencing pain or discomfort might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, you may continue systemic therapies like chemotherapy or immunotherapy during the trial, as long as your doctor agrees.

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

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe for treating cancer that has spread to the bones. Some studies have found that SBRT provides better pain relief than traditional radiation treatments. Patients have reported good results with manageable side effects.

One study focused on SBRT for cancer in the spine and found that most patients did not experience severe side effects. A review of several studies confirmed that SBRT effectively controls pain without causing serious harm to the body.

Overall, while some side effects can occur, evidence suggests that SBRT is a safe option for managing bone metastases. Discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these radiation therapy protocols for bone metastases because they potentially offer faster and more flexible treatment options compared to traditional methods. Unlike the standard radiation schedules that can extend over several weeks, these options include a standard dose administered over just three days or a high dose over five days, with the possibility of single-day treatments. This flexibility could mean less time in treatment and potentially faster relief from symptoms, which is a significant improvement in convenience and quality of life for patients.

What evidence suggests that this trial's radiation therapy treatments could be effective for bone metastases?

Research has shown that radiation therapy, including stereotactic body radiation therapy (SBRT), effectively treats cancer that has spread to the bones. Studies have found that SBRT provides pain relief comparable to traditional radiation treatments. A review of several studies found that patients who received SBRT had good cancer control and lived longer overall. Specifically, patients who underwent multiple SBRT sessions lived about 13.9 months longer on average than those who had just one session. In this trial, participants will join different treatment arms to explore the effectiveness of varying doses and schedules of radiation therapy, including SBRT, in managing bone cancer spread. ^{3 4 6 7 8}

Who Is on the Research Team?

Quynh Nguyen,, M D

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with solid primary malignancies and bone metastases, who have a life expectancy of at least 3 months. They must have adequate organ function, agree to use contraception if of childbearing potential, and be able to complete surveys. Excluded are pregnant individuals, those with prior radiation or certain treatments at the site, spinal metastases not invading paraspinal region or mechanically unstable fractures.

Inclusion Criteria

I have had surgery for bone metastases.

I can fill out surveys about my pain and quality of life.

I have bone cancer in multiple places but haven't treated more than three areas at the same time.

Exclusion Criteria

My cancer has not spread to my spine, but it may be near it.

My fracture at the treatment site is stable, either on its own or after surgery.

I have not had treatment with radioactive isotopes like Sr 89 in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard dose or high dose radiation therapy for bone metastases

1-5 days

1 visit per day for up to 5 days

Follow-up

Participants are monitored for pain response and other outcomes post-treatment

3 months

Visits at 2 weeks, 1 month, and every 3 months

Long-term follow-up

Participants are monitored for long-term outcomes such as survival and toxicity

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• Radiation Therapy

Trial Overview The study tests different doses and schedules of stereotactic body radiation therapy (SBRT) against standard palliative radiation therapy in patients with painful bone metastases. The goal is to see which method better manages pain while considering patient quality of life.

How Is the Trial Designed?

Group I: Arm 2 - High Dose Experimental Treatment 1 Intervention

Participants will receive either 1 radiation treatment a day for 5 days, or 1 radiation treatment given on 1 day.

Group II: Arm 1 - Standard Dose Experimental Treatment 1 Intervention

Participants will receive either 1 radiation treatment a day for 3 days in a row (not counting weekends or holidays), or Participants will receive 1 radiation treatment given on 1 day.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study of 260 men with localized prostate cancer treated with high-dose IGRT and IMRT, the combination resulted in a low rate of late toxicity, with only 4.4% experiencing grade 2 gastrointestinal issues and 7.1% with grade 2 genitourinary issues after 7 years.

The treatment showed high efficacy, with a 7-year prostate-specific antigen relapse-free survival rate of 97.1% for low-risk patients, indicating that this approach is both safe and effective for managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Results of IGRT in Prostate Cancer Treatment. Doležel, M., Odrážka, K., Vaňásek, J., et al.[2021]

Palliative radiotherapy is an effective treatment for painful bone metastases in urological carcinoma, characterized by rapid initiation and a short overall treatment time.

This approach typically involves a single fraction of radiation, which leads to efficient and lasting pain relief with reduced side effects, making it a valuable part of a comprehensive treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiotherapy indications in the treatment of metastases from urological malignancies]. Nguyen, TD., Lebret, T., Méjean, A.[2008]

Radiotherapy (RT) is an important treatment for spinal bone metastases, with studies showing that an 8 Gy single-fraction RT can effectively relieve pain, although optimal dosing for spinal cord compression remains unclear.

Advanced techniques like stereotactic body RT (SBRT) and intensity-modulated RT (IMRT) offer promising results in controlling tumors while reducing toxicity, making them suitable for localized cases or re-irradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current status and future of radiotherapy for spinal bone metastases. Ejima, Y., Matsuo, Y., Sasaki, R.[2018]

Radiotherapy is effective but carries specific safety risks due to the high doses of radiation used, making human oversight crucial for safe practice.

A systematic approach to prevent accidental exposures in radiotherapy is recommended, including assigning responsibilities, learning from past incidents, and proactively identifying potential hazards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tools for risk assessment in radiation therapy. Ortiz López, P.[2019]

In a study of 658 patients with high-risk endometrial cancer, intensity-modulated radiation therapy (IMRT) was associated with significantly fewer grade ≥2 adverse events, such as diarrhea and hematologic issues, compared to 3-dimensional conformal radiation therapy (3DCRT) during follow-up.

IMRT also showed a trend towards fewer patient-reported symptoms like bowel urgency and abdominal cramps during treatment, indicating it may provide a better quality of life for patients undergoing radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy. Wortman, BG., Post, CCB., Powell, ME., et al.[2022]

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

This study is a randomized controlled trial involving 60 patients with spinal bone metastases, comparing the effectiveness of single-fraction intensity-modulated radiation therapy (1 × 24 Gy) versus fractionated radiation therapy (10 × 3 Gy) for pain relief.

The primary goal is to assess pain relief at 3 months post-treatment, along with secondary outcomes including quality of life and local tumor control, highlighting the potential of SBRT as a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial. Rief, H., Katayama, S., Bruckner, T., et al.[2018]

Intraoperative radiotherapy (IORT) is an emerging treatment option for early-stage breast cancer that aims to reduce the volume of treatment, minimize toxicity, and shorten treatment duration after breast-conserving surgery.

The implementation of IORT in community cancer centers involves various challenges, including licensing, staffing, technical support, and reimbursement, which need to be addressed for successful adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiotherapy for breast cancer: its perceived simplicity. Ash, RB., Williams, VL., Wagman, LD., et al.[2013]

Intraoperative radiotherapy (IORT) allows for the precise delivery of high doses of radiation directly to tumors during surgery, improving the therapeutic ratio by maximizing tumor dose while minimizing exposure to surrounding healthy tissues.

IORT has shown efficacy in treating various cancers, including early-stage breast cancer and recurrent tumors, and has become more accessible due to advancements in technology, such as mobile linear accelerators and low-kV devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiotherapy: review of techniques and results. Pilar, A., Gupta, M., Ghosh Laskar, S., et al.[2020]

Prostate cancer patients receiving image-guided radiotherapy (IGRT) experienced significantly less severe acute toxicity, such as urinary frequency, diarrhoea, and fatigue, compared to those who did not receive IGRT, with 23% vs 7% for urinary frequency ≥G3 and 15% vs 3% for diarrhoea ≥G2.

The onset of these toxicities was earlier in the non-IGRT group, indicating that IGRT not only reduces the severity of symptoms but also delays their onset, leading to a more tolerable treatment experience for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity in prostate cancer patients treated with and without image-guided radiotherapy. Gill, S., Thomas, J., Fox, C., et al.[2021]

Intraoperative radiotherapy (IORT) for early-stage breast cancer significantly improves radiation-related quality of life (QoL) parameters, with patients reporting less pain and better functioning compared to those receiving external beam radiotherapy (EBRT).

In a study of 230 women, those treated with IORT alone experienced fewer breast and arm symptoms and better overall role functioning, indicating that IORT may be a more patient-friendly option than traditional EBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A. Welzel, G., Boch, A., Sperk, E., et al.[2021]

Intraoperative radiation therapy (IORT) allows for targeted radiation delivery during surgery, which can enhance local control of tumors while minimizing damage to surrounding healthy tissues, making it particularly beneficial for patients with locally advanced or recurrent cancers.

The addition of IORT to standard treatment regimens has shown improved local control and survival rates in various cancers, including rectal cancer and breast cancer, suggesting its potential for broader application in clinical practice as new, cost-effective devices become available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiation therapy. Willett, CG., Czito, BG., Tyler, DS.[2022]

Intraoperative radiotherapy (IORT) was used in a study involving 1367 patients with 1400 tumors, showing a 5-year local recurrence rate of 5.98% for those receiving IORT only, which is comparable to other IORT studies but higher than standard whole breast radiation therapy (WBRT).

IORT offers benefits such as convenience and low complication rates, making it a viable option for patients meeting specific criteria, although the addition of WBRT was found to significantly reduce the risk of local recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). Silverstein, MJ., Epstein, MS., Chen, P., et al.[2022]

Stereotactic body radiotherapy (SBRT) offers a promising treatment option for painful bone metastases, delivering high doses of radiation accurately over one to a few sessions, which may improve patient outcomes compared to conventional radiotherapy.

SBRT is particularly beneficial for treating tumors that are usually resistant to radiation, although it is important to consider potential toxicity to surrounding healthy tissues and the patterns of local treatment failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy in the management of painful bone metastases. Jhaveri, P., Teh, BS., Bloch, C., et al.[2008]

Image-guided stereotactic body radiation therapy (SBRT) is an effective treatment for pain control in patients with vertebral oligometastasis, potentially offering better outcomes than conventional external-beam radiation therapy.

SBRT allows for the delivery of high doses of radiation with minimal toxicity, which may improve local tumor control, especially in tumors that are typically resistant to radiation, although more research is needed to understand long-term effects on normal tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond the conventional role of external-beam radiation therapy for skeletal metastases: new technologies and stereotactic directions. Yu, HH., Hoffe, SE.[2017]

Citations

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study protocol for a randomized controlled trial - PubMed Central External beam radiotherapy has an established role in the management of patients with bone metastases of the spine. The fractionation schedule ...

2. 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.

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

Clinical Outcomes After Stereotactic Body Radiation ... We performed a systematic review and meta-analysis to characterize local control (LC), overall survival (OS), pain response rates, and toxicity after SBRT.

4. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00239-7/fulltext

A Prospective Study Assessing the Efficacy and Toxicity of ... A prospective study assessing the efficacy and toxicity of stereotactic body radiation therapy for oligometastatic bone metastases.

5. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-024-02547-x

Stereotactic radiotherapy for patients with bone metastases Median overall survival was shortest after 8-Gy single-fraction irradiation (4.2 months) and longest after stereotactic multi-fraction treatment (13.9 months).

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

Efficacy and safety of SBRT for spine metastases In this study, we summarize the available evidence for stereotactic body radiotherapy (SBRT) in the treatment of spinal metastases. Materials ...

8. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00002-2/fulltext

Clinical Outcomes Among Patients Treated With ... There are limited data regarding outcomes after stereotactic body radiation therapy (SBRT) for femur metastases, which was an exclusion criteria.