41 Participants Needed

Palliative Radiation for Lung Cancer

Recruiting at 8 trial locations
AI
AS
DG
Overseen ByDaphna Gelblum, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Systemic therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

Research Team

JM

Jennifer Ma, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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
I am 18 years old or older.
My stage IV lung cancer is causing symptoms or is close to causing symptoms.
See 3 more

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

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

Treatment Details

Interventions

  • Cyclical Hypofractionated Palliative Radiation (Quad Shot)
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+