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

Trial Summary

What is the purpose of this trial?

This study will test whether reduced-dose radiotherapy is an effective treatment for metastatic tumors with an ATM mutation. The researchers want to find the lowest dose of radiation that would still be effective to treat these tumors.

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 data supports the effectiveness of the treatment Palliative Radiotherapy for Cancer?

Palliative radiotherapy is effective in relieving pain, bleeding, and other symptoms in advanced cancer patients, and it can even extend survival for some. It is well-tolerated and can provide rapid relief, making it a valuable option for patients with both good and poor prognosis. ^{1 2 3 4 5}

Is palliative radiotherapy generally safe for humans?

Palliative radiotherapy is generally well-tolerated and considered safe for humans, as it is used to relieve symptoms in advanced cancer patients. However, it has been associated with an increased risk of death within 30 days for some patients, so careful assessment is important. ^{1 2 3 4 5}

How is palliative radiotherapy different from other cancer treatments?

Palliative radiotherapy is unique because it focuses on relieving symptoms like pain and bleeding in advanced cancer, rather than trying to cure the disease. It can provide quick relief with minimal side effects, and is often used even for patients with a poor prognosis to improve their quality of life. ^{3 4 5 6 7}

Research Team

Amy Xu, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comprehensive assessment during palliative radiotherapy consultation optimizes supportive care for patients with advanced breast cancer. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Palliative radiotherapy and the introduction of a Rapid Access Palliative Clinic in a national radiation oncology network. [2023]

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

Palliative Radiotherapy for Advanced Cancers: Indications and Outcomes. [2021]

4. India pubmed.ncbi.nlm.nih.gov

Profile of patients undergoing palliative radiotherapy: A single-institute study from a tertiary care oncology center. [2022]

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

Analysis of patterns of palliative radiotherapy in north west India: a regional cancer center experience. [2022]

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

A Palliative Radiation Oncology Consult Service's Impact on Care of Advanced Cancer Patients. [2019]

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

Palliative radiotherapy: current status and future directions. [2022]