Palliative Radiation for Lung Cancer

Not currently recruiting at 8 trial locations

Overseen By Daphna Gelblum, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Systemic therapy

Disqualifiers: Previous radiotherapy, Serious co-morbidities, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety of a new radiation therapy schedule called Quad Shot for individuals with advanced non-small cell lung cancer (NSCLC) who are also undergoing chemotherapy. Quad Shot reduces the number of days required for radiation, minimizing disruption to ongoing cancer treatments. The trial will explore various schedules to assess their effectiveness and impact on patients. It suits individuals with stage IV NSCLC who experience symptoms like cough or difficulty breathing and are already planning to receive specific chemotherapy drugs. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new therapy.

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

The trial does not specify if you need to stop your current medications. However, it seems you can continue with your existing systemic therapy for lung cancer while participating.

What prior data suggests that Quad Shot radiation therapy is safe for people with advanced NSCLC?

Research has shown that Quad Shot radiation therapy is safe and can be administered effectively up to three times. Studies have found that patients generally tolerate this treatment well, even when combined with other cancer therapies for lung tumors. Specifically, these studies found that patients typically handle the treatment without major issues. In other words, they did not experience significant side effects beyond those normally expected with radiation therapy. This suggests that Quad Shot can be a manageable option for those undergoing treatment for advanced lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for lung cancer?

Researchers are excited about Quad Shot Radiation for lung cancer because it offers a more convenient and potentially less burdensome treatment schedule compared to traditional radiation therapy. Unlike standard treatments that typically require daily sessions over several weeks, Quad Shot delivers higher doses of radiation in just two days per cycle, with a break of 21-28 days between cycles. This approach not only reduces the overall time patients spend undergoing treatment but also aligns with chemotherapy schedules, potentially enhancing the effectiveness of both treatments. This method could improve patients' quality of life by minimizing hospital visits and maximizing the impact of each radiation session.

What evidence suggests that Quad Shot radiation is effective for advanced NSCLC?

Research has shown that Quad Shot radiation therapy, which participants in this trial will receive, effectively eases symptoms in lung cancer patients. Studies have demonstrated that this treatment offers quick and lasting relief by delivering radiation in fewer, larger doses, matching the effectiveness of longer, traditional schedules. This method helps manage symptoms and improve patients' quality of life. Patients generally tolerate these treatments well, experiencing positive results in symptom relief and tumor reduction. ^{3 5 6 7 8}

Who Is on the Research Team?

Jennifer Ma, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced stage IV non-small cell lung cancer (NSCLC) who have symptoms or are about to get them. They must be able to consent, have a performance status indicating they can care for themselves, and plan on systemic therapies. Pregnant women, those previously treated at the same site with radiotherapy, or individuals with serious health issues preventing radiotherapy cannot join.

Inclusion Criteria

Able to provide informed consent

My stage IV lung cancer is causing symptoms or is close to causing symptoms.

I can care for myself but may need occasional help.

Exclusion Criteria

I've had radiation before where they now want to treat, and can't have more without risking harm.

Pregnant or breast-feeding women

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive up to 3 cycles of Quad Shot Radiation therapy, with each cycle involving 3.7 Gy twice daily for 2 days, followed by a 21-28 day break

Up to 3 months

Observation

A 3-month observation period post-radiation therapy to evaluate acute toxicity

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cyclical Hypofractionated Palliative Radiation (Quad Shot)

Trial Overview The study tests Quad Shot radiation therapy's safety in two different schedules alongside systemic cancer treatments for NSCLC patients. It aims to see if this condensed radiation schedule is effective and less disruptive compared to traditional methods.

How Is the Trial Designed?

Group I: Quad Shot Radiation Experimental Treatment 2 Interventions

In this trial, patients with centrally located lung tumors will be treated with up to 3 cycles of Quad Shot Radiation. Radiation treatment will be given within 1 week of administration of chemotherapy. Quad Shot radiation will involve: 3.7 Gy twice daily x 2 days for a total dose of 14.8 Gy per cycle. The next cycle will occur after a 21-28 day break. The first group of patients will be treated with 2 cycles of quad shot radiation, followed by a 3-month observation period post-RT to allow a complete evaluation of acute toxicity. The next group of patients will be treated with either 1 cycle or 3 cycles of quad shot radiation. The minimum accrual is 4 patients with an expected accrual of 16 patients. Twenty additional patients will be recruited to an expansion cohort.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04384146

Radiation Therapy to Relieve Symptoms in Patients With ... In this trial, patients with centrally located lung tumors will be treated with up to 3 cycles of Quad Shot Radiation. Radiation treatment will be given within ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8777150/

Rapid and Durable Symptom Palliation With Quad Shot ... Radiobiologic effectiveness of 3 or more cycles of quad shot is reportedly comparable to that of protracted definitive RT regimens, and hypofractionation may ...

3. ascopubs.org ascopubs.org/doi/10.1200/GO.23.00253

Outcome of Hypofractionated Palliative Radiotherapy ... All palliative hypofractionated regimens used were effective in terms of symptom control, tumor response rate, and QoL, and were well tolerated.

4. researchgate.net researchgate.net/publication/384522957_A_Phase_I_Study_of_Cyclical_Hypofractionated_Palliative_Radiation_Quad_Shot_for_Lung_Tumors_in_Patients_with_Stage_IV_Non-Small_Cell_Lung_Cancer_NSCLC_Results_from_the_PROMISE_006_Trial

A Phase I Study of Cyclical Hypofractionated Palliative Radiation ... The primary outcome was discontinuation of study drug due to lack of efficacy (per definitions used in the included studies) during maintenance treatment ( ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-03599

Radiation Therapy to Relieve Symptoms in Patients with ... This phase I trial studies the side effects and best dose of cyclical hypofractionated palliative radiation therapy (Quad Shot) in relieving symptoms of ...

6. redjournal.org redjournal.org/article/S0360-3016(24)00957-X/abstract

A Phase I Study of Cyclical Hypofractionated Palliative ... Our results show that QS can be safely and feasibly delivered up to 3 cycles with concurrent systemic therapy for NSCLC patients with centrally located lung ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S036030162400957X

288 A Phase I Study of Cyclical Hypofractionated Palliative ... Our results show that QS can be safely and feasibly delivered up to 3 cycles with concurrent systemic therapy for NSCLC patients with centrally located lung ...

8. redjournal.org redjournal.org/article/S0360-3016(24)00957-X/fulltext

Results from the PROMISE 006 Trial Our results show that QS can be safely and feasibly delivered up to 3 cycles with concurrent systemic therapy for NSCLC patients with centrally located lung ...