Stereotactic Ablative Radiotherapy for Cancer

(SABR-COMET Trial)

Not currently 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

Disqualifiers: Serious comorbidities, Bone metastasis, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment called Stereotactic Ablative Radiotherapy (SABR) for cancer patients. SABR delivers high doses of precise radiation to small tumors, potentially reducing side effects and improving cancer control compared to traditional treatments. The study will compare SABR with standard chemotherapy and radiotherapy to assess its impact on survival and quality of life. Suitable candidates have cancer that has spread but not extensively, and they are not eligible for surgery. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from innovative therapy.

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 prior data suggests that this technique is safe for cancer treatment?

Research has shown that stereotactic ablative radiotherapy (SABR) is generally safe and well-tolerated. Studies have found that patients who received SABR did not experience severe long-term side effects, with no patients developing serious side effects, known as grade 3 or higher toxicities. This suggests the treatment is unlikely to cause significant harm.

One study found that SABR effectively controls cancer in the treated area, with high success rates. This indicates that the treatment works well without causing major problems. Overall, the safety of SABR appears promising for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about stereotactic ablative radiotherapy (SABR) because it offers a precise and powerful method to target cancer cells. Unlike the standard treatment options that often involve broader radiotherapy and chemotherapy, SABR delivers high doses of radiation directly to the tumor with pinpoint accuracy, minimizing damage to surrounding healthy tissue. This targeted approach not only reduces side effects but also has the potential to improve outcomes by effectively destroying cancer cells in fewer treatment sessions.

What evidence suggests that Stereotactic Ablative Radiotherapy is effective for cancer?

Research has shown that Stereotactic Ablative Radiotherapy (SABR), which participants in this trial may receive in the stereotactic arm, effectively treats some types of cancer. One study found that 94.7% of patients who received SABR had their cancer well-controlled after one year. Another study reported that 85.4% of patients were still alive after one year. Additionally, SABR has been associated with a 53% chance of patients not experiencing cancer progression over four years. These findings suggest that SABR could be a promising option for controlling cancer using precise, high-dose radiation. ^{1 6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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.

sciencedirect.com

sciencedirect.com/science/article/pii/S0169500225002429

159 Real world outcomes from lung Stereotactic Ablative ...

Outcome data from RUH Bath reinforces the efficacy of SABR in controlling early-stage lung cancer and with 86% event-free survival at 12 months, and 68.4 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38467379/

Efficacy of stereotactic ablative radiotherapy in patients ...

Results: Overall, 40 consecutive patients received SABR on 62 lesions between 2021 and 2022. The most common locations for OMD were the lungs ( ...

5.

thelancet.com

thelancet.com/journals/lancet/article/PIIS0140-6736(23)01384-3/fulltext

an open-label, randomised, phase 2 trial

In the per-protocol analysis, the 4-year event-free survival rate in the SABR group was 53% (42–67%) and in the I-SABR group was 77% (66–91%) with an HR of 0·38 ...

6.

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 ...

7.

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.

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%.

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35600391/

Safety and Efficacy of Stereotactic Ablative Radiotherapy ...

Patients with UCLC can benefit from SBRT at a dose of 56 Gy/6-8f. On the other hand, smaller PTV was associated with superior outcomes, ...