220 Participants Needed

Radiation Therapy for Bone Metastases

QN
Overseen ByQuynh Nguyen, M D
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.

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.

What data supports the effectiveness of this treatment for bone metastases?

Intraoperative radiotherapy (IORT), a component of the treatment, has shown effectiveness in improving local control and survival in various cancers, including breast cancer and recurrent colorectal cancers, by delivering precise radiation doses during surgery. This suggests potential benefits for bone metastases by targeting tumors directly while minimizing damage to surrounding healthy tissues.12345

Is radiation therapy generally safe for humans?

Radiation therapy, including techniques like image-guided radiotherapy (IGRT) and intensity-modulated radiation therapy (IMRT), is generally considered safe when performed by qualified professionals with proper safety measures in place. Studies have shown that these techniques can minimize damage to normal tissues, although they do come with specific safety concerns that require careful management.678910

How is radiation therapy unique for treating bone metastases?

Radiation therapy for bone metastases, especially using advanced techniques like stereotactic body radiotherapy (SBRT) and intensity-modulated radiotherapy (IMRT), allows for precise targeting of tumors with high doses, minimizing damage to surrounding healthy tissue and potentially providing better pain relief and tumor control compared to conventional methods.1112131415

Research Team

QN

Quynh Nguyen,, M D

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.
See 8 more

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.
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm 2 - High DoseExperimental Treatment1 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 DoseExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Findings from Research

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.
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 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.
Intraoperative radiotherapy for breast cancer: its perceived simplicity.Ash, RB., Williams, VL., Wagman, LD., et al.[2013]
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.
Intraoperative radiation therapy.Willett, CG., Czito, BG., Tyler, DS.[2022]

References

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. [2021]
Intraoperative radiotherapy for breast cancer: its perceived simplicity. [2013]
Intraoperative radiation therapy. [2022]
Intraoperative radiotherapy: review of techniques and results. [2020]
Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). [2022]
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]
7.Czech Republicpubmed.ncbi.nlm.nih.gov
Long-Term Clinical Results of IGRT in Prostate Cancer Treatment. [2021]
Acute toxicity in prostate cancer patients treated with and without image-guided radiotherapy. [2021]
Tools for risk assessment in radiation therapy. [2019]
10.United Statespubmed.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. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Beyond the conventional role of external-beam radiation therapy for skeletal metastases: new technologies and stereotactic directions. [2017]
12.United Statespubmed.ncbi.nlm.nih.gov
Stereotactic body radiotherapy in the management of painful bone metastases. [2008]
[Radiotherapy indications in the treatment of metastases from urological malignancies]. [2008]
The current status and future of radiotherapy for spinal bone metastases. [2018]
High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial. [2018]
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