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

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates the safety and effectiveness of spatiotemporal stereotactic body radiation therapy (ST-SBRT) in treating patients with solid tumors that have spread to other parts of the body (polymetastatic). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. ST-SBRT is designed to deliver radiation directly to the core of the tumor, while keeping the radiation exposure of the area around the tumor at minimal dosage.

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 data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy for Cancer?

Research shows that Stereotactic Body Radiation Therapy (SBRT) is effective for treating various types of cancer, including lung and prostate cancer, by delivering high doses of radiation precisely to the tumor, which can improve local control and survival rates while minimizing damage to surrounding healthy tissue. ^{1 2 3 4 5}

Is stereotactic body radiation therapy (SBRT) generally safe for humans?

Stereotactic body radiation therapy (SBRT) is generally considered safe for treating various cancers, including early-stage lung cancer and prostate cancer, though some studies have reported potential side effects like lung and chest wall issues. Adjustments in treatment plans can help improve safety, and long-term studies have shown manageable patient-reported side effects. ^{1 3 6 7 8}

How is Spatiotemporal Stereotactic Body Radiation Therapy (ST-SBRT) different from other treatments for cancer?

Spatiotemporal Stereotactic Body Radiation Therapy (ST-SBRT) is unique because it delivers very high doses of radiation precisely to the tumor in a small number of sessions, which can lead to high rates of local control with minimal damage to surrounding healthy tissue. This approach is particularly beneficial for treating isolated cancer sites (oligometastases) and is less invasive compared to traditional surgery. ^{1 3 9 10 11}

Research Team

Yi-Jen Chen

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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 am 18 years old or older.

I have had radiotherapy that meets specific safety guidelines.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Stereotactic radiotherapy for pulmonary oligometastases: a systematic review. [2022]

2. United States 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. [2022]

3. India 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. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

LITE SABR M1: Planning design and dosimetric endpoints for a phase I trial of lattice SBRT. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Prostate stereotactic body radiotherapy—first UK experience. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for isolated hilar and mediastinal non-small cell lung cancers. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Long-term outcomes from a prospective trial of stereotactic body radiotherapy for low-risk prostate cancer. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Spine Stereotactic Body Radiotherapy for Prostate Cancer Metastases and the Impact of Hormone Sensitivity Status on Local Control. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Multi-center evaluation of dose conformity in stereotactic body radiotherapy. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Review and uses of stereotactic body radiation therapy for oligometastases. [2022]