Stereotactic vs Palliative Radiotherapy for Cancer

Overseen By Narsis Afghari, MSc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Disqualifiers: Serious comorbidities, Malignant effusion, Brain metastasis, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of radiotherapy for patients with cancer that has spread but isn't worsening in more than 1-5 areas. The goal is to determine if a precise method called SABR (stereotactic ablative radiotherapy) helps patients live longer without disease progression compared to more general palliative radiotherapy. Researchers also aim to assess how these treatments affect quality of life and determine if one is more cost-effective. Suitable candidates have cancer that has spread to a few spots and shown some growth, but they should be able to tolerate radiotherapy. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future cancer treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on systemic therapy, you must have been on it for at least 3 months with a stable or positive response before joining the trial.

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

Research has shown that stereotactic ablative radiotherapy (SABR) is generally safe and well-tolerated for treating cancer that has spread to a few areas. In one study, only 3.8% of patients experienced serious side effects within 90 days, suggesting that most people handle SABR well. Additionally, another study found that no patients developed severe long-term side effects, indicating promising long-term safety. Overall, SABR appears to be a safe option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard palliative radiotherapy, Stereotactic Ablative Radiotherapy (SABR) is a cutting-edge technique that delivers highly focused, high-dose radiation directly to the tumor. This precision reduces damage to surrounding healthy tissue, potentially leading to fewer side effects and better quality of life for patients. Researchers are particularly excited about SABR because it can offer faster and potentially more effective treatment results compared to traditional methods, making it a promising option for improving cancer care.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that stereotactic ablative radiotherapy (SABR), which participants in this trial may receive, holds promise for cancer treatment. Studies have found that SABR effectively controls the tumor area, with a success rate of about 94.7%. Additionally, one year after treatment, 85.4% of patients remained alive. Some reports indicate that SABR can extend the average survival time by 22 months compared to other treatments. Moreover, SABR carries a low risk of severe side effects, making it a safer option for many patients. Overall, these findings suggest that SABR could effectively manage cancer progression. Participants in this trial may also receive palliative radiotherapy, which serves as the control arm for comparison. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic cancer showing limited progression (1-5 lesions). Participants must be eligible for radiotherapy and have not received prior SABR or palliative radiation to the oligoprogressive sites. They should be able to undergo MRI scans, provide informed consent, and meet other health criteria.

Inclusion Criteria

Negative urine pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of radiotherapy start date

Restaging completed within 12 weeks prior to randomization

Able to provide informed consent

Exclusion Criteria

My liver cancer is in a critical area.

My liver is not working well due to cancer spread.

I have health conditions that prevent me from receiving radiotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either SABR or palliative conventional radiotherapy to all sites of oligoprogression

6 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

60 months

Regular visits at 3, 6, 12, 15, 18, 21, 24, 36, 42, 48, 54, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Palliative radiotherapy
• Stereotactic ablative radiotherapy (SABR)

Trial Overview The STOP-2 trial compares Stereotactic Ablative Radiotherapy (SABR) against conventional Palliative Radiotherapy in patients with a few progressing cancer spots. It's double-blind, meaning neither participants nor researchers know who gets which treatment. The goal is to see if SABR improves survival without disease worsening and quality of life.

How Is the Trial Designed?

Group I: Experimental Arm (SABR) Experimental Treatment 1 Intervention

Group II: Control Arm (Palliative Radiotherapy) Active Control 1 Intervention

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Published Research Related to This Trial

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

Stereotactic ablative radiotherapy (SABR) demonstrated a high local control rate of 91.2% for skeletal metastases in a study of 22 patients, with a median follow-up of 15.6 months, indicating its effectiveness in managing oligometastatic and oligoprogressive diseases.

The treatment resulted in significant pain control for two-thirds of symptomatic patients, with limited toxicities reported, including only two vertebral fractures and one case of grade 3 esophagitis, suggesting that SABR is a safe option for patients with skeletal metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of stereotactic ablative radiotherapy in oligometastatic & oligoprogressive skeletal metastases: Results and pattern of failure. Kam, TY., Chan, OSH., Hung, AWM., et al.[2019]

A consensus document was created by trial management groups from six UK studies on stereotactic ablative radiotherapy (SABR) to establish updated organ at risk dose constraints, enhancing safety during treatment.

This unified approach aims to standardize the implementation of SABR across the UK, enabling better comparisons of toxicity and efficacy between different SABR studies both nationally and internationally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy. Hanna, GG., Murray, L., Patel, R., et al.[2022]

Stereotactic ablative radiation therapy (SABR) for stage I lung cancer at Sheba Medical Center showed a median overall survival of 46 months and a 3-year survival rate of 59%, indicating its efficacy as a treatment for inoperable patients.

The treatment demonstrated excellent local control at 88% and had manageable toxicity, with only 8.4% of patients experiencing chest wall pain and a low incidence of severe side effects, suggesting it is a safe option for patients with early-stage lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiation for Stage I Lung Cancer in Israel: A Retrospective Single-Center Report. Appel, S., Lawrence, YR., Goldstein, J., et al.[2022]

Stereotactic ablative radiotherapy (SABR) has rapidly expanded in clinical use for treating various primary and metastatic tumors, demonstrating promising results in tumor control.

Despite its effectiveness, SABR can lead to serious complications, highlighting the need for strategies to reduce these risks and improve the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. Lo, SS., Sahgal, A., Chang, EL., et al.[2018]

Stereotactic ablative radiotherapy (SABR) is a promising treatment option for extracranial tumors, demonstrating both safety and effectiveness when applied with strict adherence to technical guidelines.

The treatment has a very narrow therapeutic window, meaning precise delivery is crucial for maximizing its benefits while minimizing risks to surrounding healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical know-how in stereotactic ablative radiotherapy (SABR). Lo, SS., Foote, M., Siva, S., et al.[2022]

Stereotactic ablative radiation therapy (SABR) was found to be effective for treating pulmonary metastases, with a median follow-up of 23 months showing improved overall survival (OS) for patients with 3 or fewer metastases compared to those with more (74.2% vs. 59.3% at 24 months).

Patients with less responsive primary tumors (like adrenal or pancreatic cancers) had higher local failure rates, suggesting that higher doses of SABR or surgical options may be necessary for these cases to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. Pasalic, D., Lu, Y., Betancourt-Cuellar, SL., et al.[2021]

In a study of 40 patients with central and ultracentral non-small cell lung cancer (NSCLC) treated with stereotactic ablative radiotherapy (SABR), those with ultracentral tumors experienced worse overall survival (OS) and progression-free survival (PFS) compared to those with central tumors, indicating a need for careful consideration in treatment planning.

The incidence of severe treatment-related toxicities (grade ≥3) was higher in the ultracentral group, with 12.5% of patients experiencing significant complications, including severe bronchial obstruction and esophageal perforation, highlighting the potential risks associated with SABR in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes in patients with central and ultracentral non-small cell lung cancer treated with stereotactic body radiotherapy: single-institution experience. Song, X., Zhao, L., Jiang, N., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5601509/

A systematic review of outcomes following stereotactic ... Although not statistically significant, the 3- and 5- year survival rates for the patients who received SABR plus adjuvant chemotherapy were 80.5% and 46%, ...

2. oncodaily.com oncodaily.com/oncolibrary/radiotherapy/stereotactic-radiotherapy-success

Success Rate and Survival After Stereotactic Radiotherapy Estimated 1-year outcomes included a high local control rate of 94.7%, overall survival of 85.4%, and progression-free survival of 51.4%. The ...

3. jto.org jto.org/article/S1556-0864(24)00763-9/fulltext

Historical Versus Modern Data of Stereotactic Ablative ... The results support the utilization of SABR for these patients (with a 90-day toxicity rate of 3.8% and a 90-day all-cause mortality of 1.7%), but more ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.20.00818

Long-Term Results of the SABR-COMET Phase II ... In this long-term report from an international randomized phase II trial, patients who received SABR demonstrated a 22-month improvement in median OS.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1556086415317287

Outcomes of Stereotactic Ablative Radiotherapy for ... Our main conclusion is that SABR can achieve cures in patients with central, high-risk tumors with a low incidence of high-grade toxicity. TABLE 4. Published ...

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2773455

Safety and Survival Rates Associated With Ablative ... The findings of this study suggest that stereotactic ablative radiotherapy is generally safe and well tolerated in the oligometastatic setting.

7. redjournal.org redjournal.org/article/S0360-3016(25)06209-1/abstract

5-year survival and safety of stereotactic ablative ... No patients developed ≥G3 late toxicities. The 3-, 5-year LR-FS rates were 64 ± 7%, 64 ± 7%, respectively. Multivariate analysis revealed SCC (p ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301623003255

Safety and Efficacy Results From iSABR, a Phase 1 Study ... In patients with ES-NSCLC, SABR is highly successful with reported 5-year local control rates of approximately 90%.