Stereotactic Ablative Radiotherapy for Cancer

(SABR-COMET Trial)

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1-3 weeks

99 Participants Needed

Trial Summary

What is the purpose of this trial?

Stereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with older treatments. This improvement could help by reducing side effects and by improving the chance of controlling the cancer by more precisely treating the cancer. The purpose of this study is to compare SABR with current approaches of chemotherapy and conventional radiotherapy to assess the impact on overall survival and quality of life.

Will I have to stop taking my current medications?

The trial requires that you do not take any systemic therapy (like chemotherapy) for 4 weeks before starting the radiotherapy, during the radiotherapy, and for two weeks after the last session. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment Stereotactic Ablative Radiotherapy for Cancer?

Research shows that stereotactic ablative radiotherapy can improve survival in patients with a small number of metastases from cancers like breast, colorectal, prostate, and lung, compared to standard palliative radiation. It is also a recommended treatment for early-stage non-small-cell lung cancer, offering similar survival rates to surgery for some patients. ^{1 2 3 4 5}

Is stereotactic ablative radiotherapy (SABR) generally safe for humans?

Stereotactic ablative radiotherapy (SABR) has been studied for safety in various conditions, including prostate cancer, with trials showing it is generally safe when proper dose constraints are followed. Most reported incidents related to SABR were minor, with no life-threatening events, and were often due to human errors rather than the treatment itself. ^{6 7 8 9 10}

How is stereotactic ablative radiotherapy different from other cancer treatments?

Stereotactic ablative radiotherapy is unique because it delivers highly focused radiation in one or a few sessions, targeting the tumor precisely while minimizing damage to surrounding healthy tissue. This makes it particularly effective for patients who cannot undergo surgery, offering a non-invasive alternative with excellent local control of the cancer. ^{3 5 11 12 13}

Research Team

David Palma, MD

Principal Investigator

London Regional Cancer Program of the Lawson Health Research Institute

Suresh Senan, MRCPFRCR,PhD

Principal Investigator

Amsterdam UMC, location VUmc

Eligibility Criteria

This trial is for adults over 18 with a life expectancy of more than 6 months and confirmed metastatic cancer. They should have had no systemic therapy in the month before radiotherapy, be able to consent, and have an ECOG performance status of 0-1. All cancer sites must be treatable with SABR, which excludes those with certain brain or bone metastases or previous treatments like surgery that can't be followed by SABR.

Inclusion Criteria

I haven't had any cancer treatment in the last 4 weeks.

My treated cancer spread is under control, or if not, it can be treated with SABR after surgery.

Willing to provide informed consent

Exclusion Criteria

I have health conditions that prevent me from receiving radiotherapy.

I have 1-3 brain tumors and no cancer in other parts of my body.

I have had radiation therapy on the area that now needs treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic ablative radiotherapy (SABR) or standard palliative radiotherapy

1-3 weeks

Multiple visits for radiotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Optional continuation of treatment or additional monitoring

Treatment Details

Interventions

• palliative radiotherapy
• Stereotactic ablative radiotherapy

Trial Overview The study compares Stereotactic Ablative Radiotherapy (SABR), a precise high-dose radiation treatment given over 1-3 weeks, to conventional chemotherapy and radiotherapy. It aims to see if SABR offers better control of cancer with fewer side effects, thus improving survival rates and quality of life.

Participant Groups

Group I: Stereotactic arm Experimental Treatment 1 Intervention

Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist

Group II: Standard arm Active Control 1 Intervention

Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Regional Cancer Program, Canada

Collaborator

Trials

11

Recruited

1,300+

VU University of Amsterdam

Collaborator

Trials

103

Recruited

92,500+

Findings from Research

In a study of 855 patients with early-stage non-small-cell lung cancer treated with stereotactic ablative radiotherapy, the 3-year and 5-year local control rates were high at 92.4% and 90.9%, respectively, indicating the treatment's efficacy in preventing local recurrences.

The study found that 16.7% of patients developed second primary lung cancers (SPLC) within 5 years, highlighting the need for long-term follow-up with CT scans to monitor for both local recurrences and SPLC in patients who are eligible for further radical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of Disease Recurrence after SABR for Early Stage Non-Small-Cell Lung Cancer: Optimizing Follow-Up Schedules for Salvage Therapy. Verstegen, NE., Lagerwaard, FJ., Hashemi, SM., et al.[2022]

Stereotactic radiotherapy is an effective treatment for patients with stage I non-small cell lung cancer who cannot undergo surgery, showing comparable overall survival rates to those who can have surgery.

This treatment is also well tolerated and has been successfully used for pulmonary oligometastases, highlighting the importance of early recurrence detection for patients who may still be eligible for curative surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Assessment of the response following stereotactic irradiation of lung primary tumors and metastases]. Barillot, I., Munier, O., Hatime, M., et al.[2016]

In a prospective phase II trial involving 110 patients aged 70 and older with localized prostate cancer, stereotactic body radiotherapy (SBRT) demonstrated a severe toxicity rate of less than 5%, confirming its safety for this patient population.

The SBRT regimen resulted in a biochemical progression-free survival (bPFS) rate of 90% over a median follow-up of 36 months, indicating its efficacy in treating localized prostate cancer without negatively impacting patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. Nguyen, P., Harzée, L., Retif, P., et al.[2022]

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 body radiotherapy (SBRT) is shown to be safe and effective for treating node-positive prostate cancer, with a median follow-up of 30 months revealing no severe gastrointestinal toxicities and manageable genitourinary side effects.

In a study of 60 patients, SBRT resulted in a 3-year overall survival rate of 89% and a biochemical failure-free survival rate of 77%, indicating promising long-term outcomes even in patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. Telkhade, T., Murthy, V., Kanala, TS., et al.[2021]

Out of 221 reported incidents related to CyberKnife™ SRS and SBRT from 2012 to 2019, the majority (205 incidents) had little to no clinical impact, indicating a high level of safety in the treatment process.

Human performance issues were the most common contributing factor (79% of incidents), with many errors occurring during pre-treatment phases, highlighting the need for improved training and protocols to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common Error Pathways in CyberKnife™ Radiation Therapy. Mullins, BT., Mazur, L., Dance, M., et al.[2020]

Stereotactic ablative radiotherapy is now a standard treatment for patients with medically inoperable stage I non-small-cell lung cancer and certain lung metastases, highlighting its efficacy in these cases.

The use of techniques to freeze or limit tumor movement, along with image-guided radiation delivery, is crucial for ensuring effective treatment while protecting surrounding healthy tissues from radiation overdose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-surgical treatment of lung cancer: personalised stereotactic ablative radiotherapy. Tsang, MW., Kam, MK., Leung, SF., et al.[2016]

References

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

SABR Combats Metastatic Disease. [2019]

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

Patterns of Disease Recurrence after SABR for Early Stage Non-Small-Cell Lung Cancer: Optimizing Follow-Up Schedules for Salvage Therapy. [2022]

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

The role of stereotactic ablative radiotherapy in oncological and non-oncological clinical settings: highlights from the 7th Meeting of AIRO--Young Members Working Group (AIRO Giovani). [2018]

4. France pubmed.ncbi.nlm.nih.gov

[Assessment of the response following stereotactic irradiation of lung primary tumors and metastases]. [2016]

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

A radiation oncologist's and thoracic surgeon's view on the role of stereotactic ablative radiotherapy for operable lung cancer. [2013]

6. Germany pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. [2022]

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

UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Single-Fraction Stereotactic Body Radiotherapy for Oligometastatic Lymph Node Relapse in Prostate Cancer. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Common Error Pathways in CyberKnife™ Radiation Therapy. [2020]

11. China pubmed.ncbi.nlm.nih.gov

Non-surgical treatment of lung cancer: personalised stereotactic ablative radiotherapy. [2016]

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

Stereotactic ablative radiation therapy for primary lung tumors. [2011]

13. France pubmed.ncbi.nlm.nih.gov

[Linac-based stereotactic radiosurgery and radiotherapy]. [2010]