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Palliative Radiation for Lung Cancer

Phase 1

Recruiting

Led By Annemarie Shepherd, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will test whether a shorter, more intense course of radiation therapy is safe and effective for people with late-stage 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicity

Secondary outcome measures

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

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,819 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

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

$Cyclical Hypofractionated Palliative Radiation (Quad Shot) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04384146 — Phase 1$

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the present geographic scope of this research endeavor?

"This trial is currently active at 9 sites, including Memorial Sloan Kettering Bergen in Montvale and Memorial Sloan Kettering Westchester in Harrison. Additionally, there are other 6 locations where this study can be accessed."

Answered by AI

Are there still openings available in this clinical trial?

"This medical research, which was first advertised on May 7th 2020 is still recruiting participants. The trial's information has been revised most recently on September 15th 2022 as per the data hosted by clinicaltrials.gov."

Answered by AI

How many participants are currently signed up for the experiment?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, which was posted on May 7th 2020, is actively recruiting individuals for participation. The study requires 36 patients from 9 distinct medical centres to join the experiment."

Answered by AI

What health risks may be associated with Quad Shot radiation therapy?

"The safety of Cyclical Hypofractionated Palliative Radiation (Quad Shot) is estimated at a rating 1 due to its Phase 1 status, which indicates there are limited data supporting both its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

2020. "Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04384146.