Palliative Radiotherapy for Cancer

Recruiting at 7 trial locations

Overseen By Daniel Gomez

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Previous radiotherapy, Serious comorbidities, Pregnant, 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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a lower dose of palliative radiotherapy can effectively treat metastatic tumors in patients with a specific ATM mutation. Researchers aim to determine the smallest effective radiation dose for these tumors. Suitable candidates have a confirmed cancer diagnosis with at least one metastatic site and an ATM mutation. Participants should maintain a decent level of daily functioning to manage daily activities. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that palliative radiotherapy is safe for treating metastatic tumors with an ATM mutation?

Research has shown that palliative radiotherapy is usually easy for patients to handle. One study found that it is often used to relieve pain and has few side effects. Another study found that combining this treatment with immunotherapy (a cancer treatment that helps the immune system fight cancer) does not cause additional harm.

However, a 2021 study reported that 24% of patients died within 30 days after receiving palliative radiotherapy. This information is important to consider when evaluating safety. Overall, palliative radiotherapy is widely used and considered safe for many patients, but individual responses can vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Palliative radiotherapy is unique because it uses a reduced dose of radiation specifically targeted at cancer lesions that are progressing on imaging, even if they're not causing symptoms yet. Unlike traditional radiotherapy that often aims for maximum dosage to eliminate cancer cells, this approach focuses on managing and slowing the progression of asymptomatic bone metastases. Researchers are excited about this treatment because it could minimize side effects while still effectively controlling tumor growth, offering a better quality of life for patients with advanced cancer.

What evidence suggests that palliative radiotherapy might be an effective treatment for metastatic tumors with an ATM mutation?

Research has shown that palliative radiotherapy can improve the quality of life for patients with metastatic cancer and might also extend their lifespan. Although not a cure, studies indicate that palliative radiotherapy effectively manages symptoms and slows cancer growth. For patients with advanced lung cancer, it has proven especially helpful, though results may vary by individual. In this trial, participants will receive a reduced dose of radiation to radiographically progressive lesions, including asymptomatic bone metastases. The researchers aim to determine whether a lower dose can remain effective while reducing side effects and maintaining benefits. ^{6 7 8 9 10}

Who Is on the Research Team?

Amy Xu, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a life expectancy of at least 6 months who have cancer that has spread and shows a specific genetic change (ATM mutation). They should be able to undergo reduced-dose radiation therapy, not previously treated in the same area, and must agree to use effective contraception.

Inclusion Criteria

I can take care of myself and perform daily activities.

Able to provide informed consent

My cancer has spread, and I am referred for symptom relief radiation.

Exclusion Criteria

I have health conditions that prevent me from receiving radiation therapy.

My cancer has not spread to my brain or spinal cord.

I've had radiation before where we plan to treat, and can't have more without risking harm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive reduced-dose radiation to radiographically progressive lesions identified on imaging

6 weeks

Follow-up

Participants are monitored for treatment failure and radiographic progression

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Palliative radiotherapy

Trial Overview

The study is examining if lower doses of radiation can still effectively treat metastatic tumors with an ATM mutation. It aims to determine the minimum effective dose of palliative radiotherapy for these patients.

How Is the Trial Designed?

Group I: radiation Experimental Treatment 1 Intervention

Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases).

Palliative radiotherapy is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Palliative radiotherapy for:

• Bone metastases
• Spinal cord compression
• Brain metastases
• Symptomatic relief in advanced cancers

Approved in United States as Palliative radiotherapy for:

• Pain relief in bone metastases
• Spinal cord compression
• Brain metastases
• Symptomatic relief in advanced cancers

Approved in Canada as Palliative radiotherapy for:

• Symptomatic relief in advanced cancers
• Bone metastases
• Spinal cord compression
• Brain metastases

Approved in Japan as Palliative radiotherapy for:

• Symptomatic relief in advanced cancers
• Bone metastases
• Spinal cord compression
• Brain metastases

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 130 breast cancer patients, those who had consultations in a rapid access clinic received more comprehensive assessments, with significantly higher documentation of performance status and medication history compared to non-rapid access visits.

Rapid access consultations also led to more supportive care referrals and a higher rate of same-day initiation of palliative radiotherapy, highlighting the effectiveness of a dedicated multidisciplinary team in improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive assessment during palliative radiotherapy consultation optimizes supportive care for patients with advanced breast cancer. Hill, J., Alhumaid, M., Ghosh, S., et al.[2022]

In a review of 645 patients receiving palliative radiotherapy (PRT), a significant 30-day mortality rate of 15.8% was observed, highlighting the risks associated with PRT in advanced cancer patients, particularly those with lung cancer.

The implementation of a Rapid Access Palliative Clinic (RAPC) improved patient outcomes by facilitating quicker treatment, with 88% of patients receiving PRT and 75% being referred to specialist palliative care services, indicating a more efficient care process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative radiotherapy and the introduction of a Rapid Access Palliative Clinic in a national radiation oncology network. O'Leary, C., Cleary, S., Linane, H., et al.[2023]

Palliative radiotherapy (PRT) is an effective and well-tolerated treatment option for managing symptoms of advanced cancer, such as pain and bleeding, and should be considered even for patients with poor prognosis due to its ability to provide rapid relief.

Advanced PRT techniques can enhance treatment outcomes for patients with a good prognosis by maximizing tumor control while minimizing side effects, making it a valuable part of comprehensive cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Radiotherapy for Advanced Cancers: Indications and Outcomes. Williams, GR., Manjunath, SH., Butala, AA., et al.[2021]

In a study of 516 cancer patients receiving palliative radiotherapy (PRT), pain relief was the most common reason for treatment, with a response rate of about 43% observed two weeks after completion.

The study supports the use of hypofractionated radiotherapy, which involves delivering higher doses in fewer sessions, as an effective and convenient option for symptom palliation in patients with advanced, incurable cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of patterns of palliative radiotherapy in north west India: a regional cancer center experience. Kapoor, A., Singhal, MK., Kumar, N., et al.[2022]

The establishment of the Palliative Radiation Oncology Consult (PROC) service led to more efficient treatment for advanced cancer patients, with a significant increase in the use of single-fraction and hypofraction radiation, resulting in shorter hospital stays (21 days compared to 26.5 days).

Patients treated after the PROC service received palliative care consultations more quickly, and despite the shorter treatment durations, they experienced similar levels of symptom relief, indicating that the quality of care was maintained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Palliative Radiation Oncology Consult Service's Impact on Care of Advanced Cancer Patients. Chang, S., May, P., Goldstein, NE., et al.[2019]

Palliative radiotherapy has been an effective treatment for nearly 100 years, providing symptom relief for patients with metastatic or advanced cancer, often using short courses or single fractions to minimize side effects and enhance convenience.

Recent advancements in imaging and radiotherapy techniques, such as intensity-modulated radiotherapy (IMRT) and stereotactic radiotherapy (SRT), allow for more effective local control and longer-lasting palliative responses, even in patients who may not yet show symptoms of advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative radiotherapy: current status and future directions. Sharma, S., Hertan, L., Jones, J.[2022]

In a study of 460 cancer patients over 2 years, palliative radiotherapy (PRT) was found to significantly improve symptoms in 442 patients, highlighting its effectiveness in managing pain and other symptoms associated with advanced malignancies.

The most common use of PRT was for pain relief from metastases, particularly in lung cancer patients, indicating that short courses of PRT are a preferred treatment option to enhance the quality of life for patients with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profile of patients undergoing palliative radiotherapy: A single-institute study from a tertiary care oncology center. Suhag, V., Sunita, BS., Vats, P., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6375451/

Palliative Radiotherapy for the Management of Metastatic ...

Although palliative RT does not provide a chance for a cure, it improves QOL and may prolong survival time. An estimated 20% to 50% of radiation courses are ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1053429623000036

Prognostication for Patients Receiving Palliative Radiation ...

Group 1 (scores >7) had the best prognosis (median survival not reached), while Group 4 (score <1) had the worse with median survival 9.1 months. Median ...

3.

oncodaily.com

oncodaily.com/oncolibrary/radiotherapy/life-expectancy-after-palliative-radiotherapy

Life Expectancy After Palliative Radiotherapy

Long-term effects of palliative radiotherapy can include fatigue, tissue damage, and in some cases, the development of secondary cancers. ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8213366/

Patient-Reported Outcomes Assessing the Impact of Palliative ...

A recent prospective clinical cohort study reported a 1-year overall survival of only 32% for head and neck cancer patients treated in “non-curative” intent (2) ...

5.

bmcpalliatcare.biomedcentral.com

bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-024-01628-8

Outcomes of patients receiving urgent palliative radiotherapy ...

Palliative radiotherapy was effective for patients with advanced lung cancer, although response rates varied by patient characteristics and treatment ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40926936/

Evaluating the Oncologic and Safety Outcomes of High ...

Evaluating the Oncologic and Safety Outcomes of High-Dose Palliative Radiation Treatment with 30 Grays in Five Fractions.

7.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2796618

Use and Reporting of Patient-Reported Outcomes in Trials ...

A 2021 cohort study underlined this aspect, as it reported a 30-day mortality rate of 24% in 518 patients after palliative radiotherapy.

8.

advancesradonc.org

advancesradonc.org/article/S2452-1094(25)00029-6/fulltext

Prospective Study of Patients Treated with Palliative ...

Purpose: To prospectively document the outcomes of patients treated with palliative radiation therapy (RT) who are receiving immunotherapy.

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S2452109425000296

Prospective Study of Patients Treated with Palliative ...

Palliative RT appears safe in patients receiving immunotherapy with no apparent increase in toxicity because of the combination.

10.

thegreenjournal.com

thegreenjournal.com/article/S0167-8140(23)00076-2/fulltext

Early outcomes in the FAST-METS study

Palliative care comprises 30–50 % of all radiotherapy (RT) treatments, which is an effective treatment for pain with minimal side effects [1–6] ...