What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include radiation therapy and systemic therapies such as chemotherapy. Condensed radiation schedules, like the Quad Shot Radiation Therapy, aim to reduce treatment duration but can still cause side effects such as fatigue, skin irritation, esophagitis, and pneumonitis. Systemic therapies, including chemotherapy regimens with drugs like cisplatin, etoposide, and paclitaxel, often lead to side effects such as nausea, vomiting, hair loss, myelosuppression (decreased blood cell counts), and increased risk of infection. Combining these treatments can enhance efficacy but may also increase the likelihood and severity of side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC), including various chemotherapy agents, targeted therapies, and immunotherapies. Notably, treatments like stereotactic body radiation therapy (SBRT) have been used for localized treatment of NSCLC, which is somewhat similar to the condensed radiation schedule being studied in the Quad Shot Radiation Therapy trial. Additionally, drugs such as pembrolizumab (Keytruda) and nivolumab (Opdivo) have been approved for their efficacy in treating advanced NSCLC, often in combination with chemotherapy or as monotherapy in cases with specific genetic markers or PD-L1 expression.

What other types of research exist?

Promising alternatives to Quad Shot Radiation Therapy for NSCLC patients include continuous hyperfractionated accelerated radiotherapy weekend less (CHARTWEL) and altered fractionation schedules. These approaches aim to enhance therapeutic efficacy and manage toxicity, though they may present logistical challenges. Patients should discuss these options with their oncologist to determine the best individualized treatment plan.

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Palliative Radiation for Lung Cancer

Phase 1

Waitlist Available

Led By Jennifer Ma, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Patients with Stage IV NSCLC who have symptomatic or near-symptomatic centrally located disease

Must not have

Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances

Serious medical co-morbidities precluding radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether a radiation therapy schedule may help treat lung cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Quad Shot radiation may include skin irritation at the treatment site, fatigue, difficulty swallowing if treating near the esophagus, and possible mild inflammation of lung tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I can care for myself but may need occasional help.

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My lung cancer has spread, and I have a treatment plan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicity

Secondary study objectives

Number of participants who are able to complete the assigned radiation therapy regimen (3 cycles of quad shot)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Quad Shot RadiationExperimental Treatment2 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include surgery, radiation therapy, and systemic therapies. Surgery involves the physical removal of the tumor, which is most effective in early-stage NSCLC. Radiation therapy, including condensed schedules like Quad Shot Radiation Therapy, uses high-energy rays to kill cancer cells and shrink tumors, offering a less disruptive option for patients undergoing systemic therapy. Systemic therapies include chemotherapy, which targets rapidly dividing cells; targeted therapy, which focuses on specific genetic mutations in cancer cells; and immunotherapy, which enhances the body's immune response against cancer cells. These treatments are crucial for NSCLC patients as they provide multiple avenues to control and potentially eradicate the disease, improving survival rates and quality of life.

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Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,976 Previous Clinical Trials

599,459 Total Patients Enrolled

Jennifer Ma, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Daphna Gelblum, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

2 Previous Clinical Trials

172 Total Patients Enrolled

Annemarie Shepherd, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

125 Total Patients Enrolled

Media Library

$Cyclical Hypofractionated Palliative Radiation (Quad Shot) Clinical Trial Eligibility Overview. Trial Name: NCT04384146 — Phase 1$

Non-Small Cell Lung Cancer Research Study Groups: Quad Shot Radiation

$Non-Small Cell Lung Cancer Clinical Trial 2023: Cyclical Hypofractionated Palliative Radiation (Quad Shot) Highlights & Side Effects. Trial Name: NCT04384146 — Phase 1$