Stereotactic Ablative Radiotherapy for Metastatic Cancer

(ID-COMET Trial)

Overseen By ASK RPCI

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Chemotherapy, Radiotherapy, Brain metastases, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether starting Stereotactic Ablative Radiotherapy (SABR) immediately or delaying it for three months affects survival in individuals with newly diagnosed metastatic lung, colorectal, and prostate cancers. It tests different approaches to determine the most effective one. Individuals with these cancers, who have 1-10 sites of cancer spread, may be suitable for this study. The trial seeks participants who can provide consent and have a life expectancy of more than six months. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

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, it mentions that participants should not have had chemotherapy or radiotherapy within 3 weeks (or 6 weeks for certain drugs) before entering the study, suggesting a possible need to pause some treatments.

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 for individuals with metastatic cancer. Studies indicate that SABR is well-tolerated, allowing most patients to undergo treatment without serious issues. For instance, one study found that SABR in patients with limited cancer spread did not cause severe side effects. Another study demonstrated that SABR effectively controlled cancer with few serious side effects, even in younger patients. Overall, SABR appears to be a safe option for treating metastatic cancer, with most patients experiencing only mild side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic Ablative Radiotherapy (SABR) for metastatic cancer because it offers a highly precise method of targeting tumors, potentially minimizing damage to surrounding healthy tissue. Unlike traditional radiation therapy, which often involves multiple sessions over weeks, SABR delivers high doses of radiation in fewer treatments, possibly leading to quicker results and less disruption for patients. Additionally, combining SABR with standard therapies might enhance the overall effectiveness of treatment by attacking the cancer from multiple angles, giving patients a better chance of improved outcomes.

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

Research has shown that Stereotactic Ablative Radiotherapy (SABR) might help patients with certain types of cancer that have spread to other parts of the body live longer. In this trial, researchers will assign participants to different treatment arms to evaluate SABR's effectiveness. For patients with a small number of these spread areas, known as oligometastatic cancer, SABR may be more effective than standard treatments alone. One study found that almost half of the patients prevented their cancer from worsening for at least six months. Another study reported that 89.1% of patients experienced no new cancer growth in the treated area, and 71.3% were still alive after two years. These results suggest that SABR could be a strong option for managing metastatic cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Anurag Singh, MD

Principal Investigator

Roswell Park Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed metastatic lung, colorectal, or prostate cancer. They must be willing to consent, have a life expectancy over 6 months, and an ECOG performance status of ≤3 (still active). Restaging scans should be recent. Those with signs of fibrotic interstitial lung disease need respirologist clearance.

Inclusion Criteria

I can take care of myself but cannot do heavy physical work.

My cancer has spread to other parts of my body.

I am at least 1 year old.

Exclusion Criteria

I have fluid buildup due to cancer in the lining of my lung.

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

My liver is not working well due to cancer spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Treatment

Participants receive immediate Stereotactic Ablative Radiotherapy (SABR) plus standard of care

3 months

Delayed Treatment

Participants receive SABR after a delay of three months, following standard therapy

3 months

Follow-up

Participants are monitored for survival, quality of life, and radiation-related toxicity

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Ablative Radiotherapy

Trial Overview The ID-COMET trial compares immediate versus delayed Stereotactic Ablative Radiotherapy (SABR) in patients with certain types of metastatic cancers. It's unblinded and randomized at one center to see if timing affects survival rates.

How Is the Trial Designed?

Group I: Trial 4 - Immediate SABR plus standard of care Experimental Treatment 2 Interventions

Group II: Standard Therapy followed by SABR - Trial 1-3 Arm 1 Experimental Treatment 2 Interventions

Group III: SABR plus Standard therapy - Trial 1-3 Arm 2 Experimental Treatment 2 Interventions

Stereotactic Ablative Radiotherapy is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United States as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United Kingdom as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) is effective for treating stage I lung cancer, achieving local control rates similar to those of surgical resection while minimizing side effects to surrounding healthy tissues.

SBRT is being explored for treating oligometastatic disease, although current evidence of its clinical benefits is limited; ongoing international studies aim to clarify its effectiveness and potential combinations with other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for oligometastatic disease. Hanna, GG., Landau, D.[2018]

Stereotactic body radiation therapy (SBRT) is a highly effective, noninvasive treatment for tumors, particularly in the lung and liver, offering high rates of tumor eradication with minimal recovery time required for patients.

While SBRT has a favorable overall toxicity profile, it can lead to delayed side effects such as ulceration and fibrosis, especially when treating tumors near sensitive structures like the bowel, highlighting the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergence of stereotactic body radiation therapy and its impact on current and future clinical practice. Timmerman, RD., Herman, J., Cho, LC.[2022]

Stereotactic body radiation therapy (SBRT) is an effective treatment for early-stage non-small cell lung cancer (NSCLC), providing precisely targeted radiation doses to tumors, especially for patients who cannot undergo surgery.

The review highlights the importance of SBRT in both medically inoperable cases and its potential role in operable early-stage NSCLC, indicating its growing significance in cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Early-Stage Lung Cancer. Maquilan, G., Timmerman, R.[2018]

Stereotactic body radiation therapy (SBRT) for metastatic lung tumors showed promising long-term outcomes, with 1-, 3-, and 5-year local control rates of 88.8%, 75.4%, and 75.4%, respectively, based on a study of 71 patients with 172 lesions.

The treatment was well-tolerated, with no severe toxicities reported, and only one patient experiencing a non-symptomatic rib fracture, suggesting SBRT is a safe alternative to surgery for certain patients with lung metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy favors long-term overall survival in patients with lung metastases: five-year experience of a single-institution. Zhang, Y., Xiao, JP., Zhang, HZ., et al.[2022]

In a study of 145 patients with multiple pulmonary metastases treated with stereotactic body radiotherapy (SBRT), the overall survival (OS) was 23.5 months, indicating that SBRT is effective for this condition.

The study found no increase in the risk of early death or severe toxicity (grade 4 or 5) associated with multiple SBRT treatments, suggesting a strong safety profile for this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy (SBRT) for multiple pulmonary oligometastases: Analysis of number and timing of repeat SBRT as impact factors on treatment safety and efficacy. Klement, RJ., Hoerner-Rieber, J., Adebahr, S., et al.[2018]

In a study of 40 patients with EGFR wild-type oligometastatic non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT), the median overall survival was 40 months, indicating that SBRT can be an effective treatment option for this patient group.

The study found that high-dose radiation (BED10 ≥100 Gy) was associated with better progression-free survival compared to lower doses, and the treatment was well-tolerated, with no severe toxicities reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing efficacy and safety of stereotactic body radiation therapy for oligometastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) wild type. Hu, X., Li, H., Liu, H., et al.[2022]

Stereotactic body radiation therapy (SBRT) is a preferred treatment for early-stage non-small cell lung cancer (NSCLC) patients who cannot undergo surgery, but accurate lymph node staging is crucial for optimal patient selection.

Current staging methods like PET/CT and EBUS have limited sensitivity in detecting lymph node metastases, which can lead to undetected cancer spread and poorer outcomes; thus, invasive staging procedures are often necessary to improve detection and potentially enhance survival with adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. Cerra-Franco, A., Diab, K., Lautenschlaeger, T.[2017]

In a study of 145 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic body radiotherapy (SBRT), the treatment demonstrated a high local control rate with only 24.1% experiencing disease recurrence over a median follow-up of 65.6 months.

SBRT was associated with low toxicity, as only 3.4% of patients experienced grade 3 adverse events, and no patients suffered from severe (grade 4 or 5) toxicities, indicating that it is a safe treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year follow-up after stereotactic body radiotherapy for medically inoperable early-stage non-small cell lung cancer: a multicenter study. Guo, Y., Zhu, Y., Zhang, R., et al.[2023]

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]

Stereotactic body radiotherapy (SBRT) for ultra-central lung tumors shows high efficacy, with pooled local control rates of 92% at 1 year and 89% at 2 years, based on a systematic review of 27 studies involving 1183 treated targets.

While SBRT is effective, it carries risks of severe toxicity, with a 6% incidence of grade 3-4 toxicities and a 4% incidence of treatment-related deaths, highlighting the importance of careful patient selection and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for Ultra-Central lung Tumors: A systematic review and Meta-Analysis and International Stereotactic Radiosurgery Society practice guidelines. Yan, M., Louie, AV., Kotecha, R., et al.[2023]

Stereotactic body radiotherapy (SBRT) is an effective treatment for patients with stage I non-small cell lung cancer (NSCLC) who cannot undergo surgery, with a median overall survival of 30 months for T1 tumors and 26 months for T2 tumors based on a study of 723 patients.

Higher biological equivalent doses (BED10) of SBRT significantly improve local control rates for T2 tumors, with a local failure rate dropping from 32% to 8% as the BED10 increases from <105 Gy to ≥150 Gy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for early-stage non-small cell lung cancer: clinical outcomes from a National Patient Registry. Davis, JN., Medbery, C., Sharma, S., et al.[2022]

Citations

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Stereotactic Ablative Radiotherapy for the Treatment of ... - NCBI The current clinical evidence suggests that SABR plus SOC may offer survival benefits for patients with oligometastatic cancer compared to SOC alone. However, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0748798325004846

Metastasectomy versus stereotactic body radiotherapy for ... The data suggest that patients with oligometastatic CLM have a comparable OS rate after metastasectomy or SBRT, but PFS and LRR favour a surgical approach. This ...

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2797012

Treatment With Stereotactic Ablative Radiotherapy for Up ... The trial results suggest that stereotactic ablative body radiotherapy has acceptable rates of toxic effects, and this potentially supports enrollment in phase ...

4. ascopubs.org ascopubs.org/doi/10.1200/OA-25-00031

A Phase II Prospective Multicenter Trial In this study of 32 patients, nearly half were able to stay on their current treatment without disease progression for at least 6 months, and ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-023-10635-6

Stereotactic ablative body radiotherapy with a central high ... Our results showed 2-year LC and OS rates of 89.1% and 71.3%, respectively. It also demonstrated that the outcomes of SABR using CyberKnife are ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7689573/

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. sciencedirect.com sciencedirect.com/science/article/pii/S2452109422002299

Efficacy and Safety of Stereotactic Body Radiation Therapy ... Conclusions. SBRT provided durable LC for pediatric and AYA patients with cancer with minimal severe toxicities. Dose escalation may result in improved LC for ...

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

Success Rate and Survival After Stereotactic Radiotherapy The authors concluded that SABR appears relatively safe and provides clinically acceptable control and survival rates. In a 2024 study published ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8063134/

Evaluation of Safety of Stereotactic Body Radiotherapy for the ... Standard ablative radiation schedules appear to be safe for patients with oligometastatic disease with 3 to 4 metastases or 2 metastases in close proximity to ...