Stereotactic Body Radiation Therapy for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must not be taking: Systemic therapy

Disqualifiers: Pregnancy, Breastfeeding, Serious comorbidities, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 1 year

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the use of Spatiotemporal Stereotactic Body Radiation Therapy (ST-SBRT) to treat cancer that has metastasized. The researchers aim to determine if this treatment can safely and effectively target tumors with high precision, potentially minimizing damage to nearby healthy tissue. It suits patients with more than five tumors, at least one larger than 2 cm, who have not responded to other treatments. This trial may offer hope for those with limited treatment options. As an unphased trial, it provides a unique opportunity for patients to access innovative treatments not yet widely available.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any active systemic therapy (treatment affecting the entire body) at least one month before and one month after the study intervention.

What prior data suggests that this method is safe for treating polymetastatic cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) is generally well-tolerated. One study found that using SBRT with doses of 54 Gy in 3 sessions effectively controlled the tumor in 97.6% of patients over three years, indicating the treatment's success for many. Another study reported a low tumor recurrence rate of just 4.3% at two years with doses between 54-60 Gy in 3 sessions.

These findings suggest that SBRT is both safe and effective. The treatment targets the tumor with focused radiation, aiming to protect nearby healthy tissue and reduce side effects. However, discussing potential risks and benefits with healthcare providers is important for making informed decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers high doses of radiation with pinpoint accuracy to cancerous tumors, minimizing damage to surrounding healthy tissue. Researchers are excited about Spatiotemporal SBRT because it further refines this precision by adapting to the tumor's movement and changes over time during treatment, potentially increasing effectiveness and reducing side effects. This technique could offer a significant advantage over traditional radiation therapies, which often involve broader areas and can require more sessions to achieve the same results.

What evidence suggests that spatiotemporal stereotactic body radiation therapy is effective for treating polymetastatic cancer?

Research has shown that spatiotemporal stereotactic body radiation therapy (ST-SBRT), which participants in this trial will receive, holds promise for treating solid tumors that have spread. One study found that patients with five or fewer cancer spots had a 100% chance of surviving for at least one year, compared to 50% for those with more than five spots. ST-SBRT targets radiation directly at the tumor, protecting nearby healthy tissue. This method can also deliver effective treatment in fewer sessions, offering more convenience for patients. Another study discovered that this approach could increase the amount of tumor-killing radiation by 10–20% compared to areas not targeted. Overall, these findings suggest that ST-SBRT could be a strong option for managing complex cancer cases. ^{1 2 4 6 7}

Who Is on the Research Team?

Yi-Jen Chen

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with polymetastatic cancer, meaning they have more than five tumor lesions and limited treatment options. They should be in relatively good health (Karnofsky performance status > 60), not currently on systemic therapy, and expected to live at least three months. Pregnant or breastfeeding women are excluded, as well as those unable to undergo CT scans or comply with study procedures.

Inclusion Criteria

I have had radiotherapy that meets specific safety guidelines.

My brain metastases have been treated and are stable as shown by a recent MRI.

I have had treatment for cancer that spread to my spine.

Exclusion Criteria

I have serious health issues that prevent me from receiving radiotherapy.

Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements

Unable to undergo a CT scan

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo spatiotemporal stereotactic body radiation therapy (ST-SBRT) and collection of blood samples

Up to 1 year

Multiple visits (in-person) for each ST-SBRT fraction

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CT scans and quality of life assessments

3 months

Regular follow-up visits (in-person)

Long-term follow-up

Participants' overall survival and long-term effects are monitored

Up to 1 year post initiation of study treatment

What Are the Treatments Tested in This Trial?

Interventions

• Spatiotemporal Stereotactic Body Radiation Therapy

Trial Overview The trial tests spatiotemporal stereotactic body radiation therapy (ST-SBRT) for patients with solid tumors that have spread widely. ST-SBRT aims to precisely target the core of tumors while minimizing damage to surrounding tissues, potentially offering a safer and quicker treatment option.

How Is the Trial Designed?

Group I: Treatment (ST-SBRT) Experimental Treatment 3 Interventions

Patients undergo ST-SBRT on study. Patients also undergo collection of blood samples at screening and on study and undergo CT at screening, on study, and during follow up.

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

Approved in United States as Stereotactic Body Radiation Therapy for:

• Metastatic solid tumors
• Non-small cell lung cancer
• Renal cell carcinoma
• Urothelial carcinoma
• Melanoma
• Head and neck squamous cell carcinoma

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Metastatic solid tumors
• Non-small cell lung cancer
• Renal cell carcinoma
• Urothelial carcinoma
• Melanoma
• Head and neck squamous cell carcinoma

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Metastatic solid tumors
• Non-small cell lung cancer
• Renal cell carcinoma
• Urothelial carcinoma
• Melanoma
• Head and neck squamous cell carcinoma

Approved in Japan as Stereotactic Body Radiation Therapy for:

• Metastatic solid tumors
• Non-small cell lung cancer
• Renal cell carcinoma
• Urothelial carcinoma
• Melanoma
• Head and neck squamous cell carcinoma

Approved in China as Stereotactic Body Radiation Therapy for:

• Metastatic solid tumors
• Non-small cell lung cancer
• Renal cell carcinoma
• Urothelial carcinoma
• Melanoma
• Head and neck squamous cell carcinoma

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Lattice stereotactic body radiation therapy (SBRT) effectively delivers a high dose of radiation (66.7 Gy) to tumor areas while sparing surrounding healthy tissues, achieving all planning objectives for 20 patients in a Phase I trial.

The study demonstrated improved conformity of the radiation dose over time, with most treatments completed efficiently within 30 minutes, indicating that Lattice SBRT is both effective and practical for larger tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LITE SABR M1: Planning design and dosimetric endpoints for a phase I trial of lattice SBRT. Kavanaugh, JA., Spraker, MB., Duriseti, S., et al.[2022]

In a study of 93 patients with prostate cancer receiving stereotactic body radiotherapy (SBRT) for spinal metastases, local control rates were very high, with 99% at 1 year and 95% at 2 years for hormone-sensitive prostate cancer (HSPC), but lower for castrate-resistant prostate cancer (CRPC) at 94% and 78%, respectively.

The overall survival rates were significantly better for patients with HSPC, at 98% and 95% at 1 and 2 years, compared to 79% and 65% for those with CRPC, indicating that hormone sensitivity impacts both local control and survival outcomes after SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. Abugharib, A., Zeng, KL., Tseng, CL., et al.[2022]

In a review of stereotactic body radiotherapy (SBRT) plans from 17 centers, it was found that 29% of patient plans compromised target volume coverage to meet organ-at-risk tolerances, highlighting the need for better plan quality metrics that do not rely solely on target coverage.

The study established that the prescription dose spillage (PDS) and modified gradient index (MGI) metrics provide updated guidance for evaluating SBRT plan quality, with PDS values aligning well with existing clinical trial constraints, while MGI values indicated discrepancies that need addressing for optimal treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-center evaluation of dose conformity in stereotactic body radiotherapy. Lee, J., Dean, C., Patel, R., et al.[2022]

The concept of 'oligometastases' suggests that patients with a limited number of metastatic tumors may have a chance for potential cure through local therapies, challenging the traditional view that distant metastases are always incurable.

Stereotactic body radiation therapy (SBRT) is a highly precise treatment that delivers high doses of radiation to tumors, showing promising results in local tumor control and improved survival in select patients, supported by various studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review and uses of stereotactic body radiation therapy for oligometastases. Alongi, F., Arcangeli, S., Filippi, AR., et al.[2022]

In a study of 102 patients with various stages of lung cancer, once-weekly stereotactic body radiotherapy (SBRT) achieved a high overall response rate of 75%, with 33% of patients experiencing a complete response, particularly notable in Stage IA patients with an 89% response rate.

SBRT demonstrated a favorable safety profile, with no severe acute toxicities (Grade 3-4) reported, and only 12% and 7% of patients experiencing Grade 1 and 2 toxicities, respectively, making it a viable noninvasive treatment option for elderly or medically unfit patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-weekly, high-dose stereotactic body radiotherapy for lung cancer: 6-year analysis of 60 early-stage, 42 locally advanced, and 7 metastatic lung cancers. Salazar, OM., Sandhu, TS., Lattin, PB., et al.[2022]

In a study involving 51 prostate cancer patients treated with stereotactic body radiotherapy (SBRT), the treatment showed promising outcomes with manageable toxicity levels, as no patients experienced severe (grade 3+) side effects during the initial follow-up period.

The median follow-up of 14.5 months revealed a low prostate-specific antigen level of 1.3 ng/ml at 13-18 months post-treatment, indicating effective disease control in this cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate stereotactic body radiotherapy—first UK experience. Tree, AC., Ostler, P., Hoskin, P., et al.[2022]

A 68-year-old woman treated with stereotactic body radiation therapy (SBRT) for lung metastases experienced pathological vertebral fractures ten months post-treatment, highlighting a previously unreported adverse effect of SBRT.

Despite achieving a complete response of the metastatic disease without signs of radiation pneumonitis, the case emphasizes the need for oncologists to consider the risk of bone toxicity, particularly in older patients with potential low bone mineral density (BMD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. Rodríguez-Ruiz, ME., San Miguel, I., Gil-Bazo, I., et al.[2022]

Hypofractionated stereotactic body radiotherapy (SBRT) demonstrated a 2-year local control rate of 77.9% and an overall survival rate of 53.7% in a review of 334 patients with pulmonary metastases, indicating its efficacy in managing oligometastatic cancer.

The treatment was associated with a low rate of severe toxicities (4% for SBRT and 2.6% for single fraction stereotactic radiosurgery), suggesting that SBRT is a relatively safe option for patients with limited pulmonary oligometastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy for pulmonary oligometastases: a systematic review. Siva, S., MacManus, M., Ball, D.[2022]

Hypofractionated stereotactic body radiation therapy (SBRT) for early-stage nonsmall cell lung carcinoma was found to be safe and effective, with no significant toxicity reported in a study of nine patients over an 18-month follow-up period.

Using an active breath coordinator (ABC) during treatment resulted in smaller planning target volumes and less lung exposure to radiation compared to free breathing, suggesting that ABC may enhance treatment precision without increasing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for early-stage primary lung cancer, is an active breath coordinator necessary? An audit from a tertiary cancer care center. Madhavan, R., Renilmon, PS., Nair, HM., et al.[2018]

A retrospective study of 40 patients with hilar or mediastinal non-small cell lung cancer (NSCLC) treated with SBRT showed promising results, with a median overall survival of 22.7 months and a two-year local control rate of 87.7%.

The study indicated that SBRT is a safe treatment option, with only a small number of patients experiencing acute or late severe side effects, suggesting that the alternative dose-fractionation schemes used may improve safety without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for isolated hilar and mediastinal non-small cell lung cancers. Horne, ZD., Richman, AH., Dohopolski, MJ., et al.[2018]

In a study of 67 patients with low-risk prostate cancer treated with stereotactic body radiotherapy (SBRT), significant late bladder and rectal toxicities were infrequent, with no grade 4 toxicities reported and only 3% experiencing grade 3 bladder toxicity.

The 4-year PSA relapse-free survival rate was 94%, indicating that SBRT is effective in controlling prostate cancer and should be considered as a treatment option alongside other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. King, CR., Brooks, JD., Gill, H., et al.[2022]

Citations

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Spatiotemporal Stereotactic Body Radiation Therapy for the ... This clinical trial evaluates the safety and effectiveness of spatiotemporal stereotactic body radiation therapy (ST-SBRT) in treating patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10993982/

Clinical outcomes and efficacy of stereotactic body radiation ... Patients who were treated with SBRT who had ≤5 metastatic lesions at first recurrence had a superior 1 year OS of 100 vs50% for those with >5 lesions (Figure 2B) ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814017325641

Spatiotemporal fractionation schemes for liver stereotactic ... Spatiotemporal fractionation presents a method of increasing the ratio of prescribed tumor BED to mean BED in the noninvolved liver by approximately 10–20%, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3807836/

Safety and Efficacy of Stereotactic Body Radiation Therapy in ... The Radiation Therapy Oncology Group (RTOG) phase II trial reported a 3-year local control 97.6% with 54 Gy in 3 fractions [17]. Retrospective data have ...

5. scholarlycommons.henryford.com scholarlycommons.henryford.com/cgi/viewcontent.cgi?article=1217&context=radiationoncology_mtgabstracts

Outcomes of MR-guided Stereotactic Body Radiotherapy ( ... Background: There have been recent reports on the association between radiation related lymphopenia and survival outcomes in solid tumors.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025046110

Definition and requirements for stereotactic radiotherapy Quality and Safety Considerations in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy: An ASTRO Safety White Paper Update. Pract Radiat ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301617340440

Tumor Control and Toxicity for Common Stereotactic Body ... An SBRT dose of 54-60 Gy in 3 fractions was associated with a statistically significant lower rate of local failure (LF) (4.3% at 2 years)