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

Memorial Sloan Kettering Cancer Center41 enrolled

Overview

This study will test the safety of Quad Shot radiation therapy using 2 different treatment schedules to find out what effects, if any, this treatment has on people with advanced NSCLC who are receiving systemic therapy for their cancer. The Quad Shot treatment schedule reduces the number of days needed to deliver the radiation treatments, which may be less disruptive to systemic therapy schedules.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

Cyclical Hypofractionated Palliative Radiation (Quad Shot)RADIATION

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.

EORTC QLQ-C30 questionnaireBEHAVIORAL

at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed non-small cell lung cancer with metastatic disease detected on cross-sectional imaging with a plan for one of the following systemic therapies: * Carboplatin/paclitaxel * Carboplatin/paclitaxel/pembrolizumab * Carboplatin/pemetrexed * Carboplatin/pemetrexed/pembrolizumab * Pembrolizumab (single agent or in combination with other regimens in this list) * Cisplatin/pemetrexed * Cisplatin/pemetrexed/pembrolizumab * Pemetrexed/pembrolizumab * Pemetrexed * Nivolumab (single agent or in combination with other regimens in this list) * Ipilimumab/nivolumab * Carboplatin/etoposide * Carboplatin/etoposide/atezolizumab * Cisplatin/etoposide * Cisplatin/etoposide/atezolizumab * Durvalumab (single agent or in combination with other regimens in this list) * Atezolizumab (single agent or in combination with other regimens in this list) * Patients eligible for the systemic therapy regimens notes * Patients with Stage IV NSCLC who have symptomatic (defined by patient-reported cough, dyspnea, or hemoptysis) or near-symptomatic (determined radiographically to be threatening the airway, esophagus or vasculature) centrally located. * KPS ≥ 60 * Age ≥ 18 years. * Able to provide informed consent. * Patients at reproductive potential must agree to practice an effective contraceptive method. Exclusion Criteria: * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances. * Serious medical co-morbidities precluding radiotherapy. * Pregnant or breast-feeding women.

Locations (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, United States

Outcomes

Primary Outcomes

Dose Limiting Toxicity

Dose Limiting Toxicity will be defined by CTCAE v5 grade 3 or higher for Esophagitis, Pneumonitis, Bronchial, bronchopleural or tracheal fistula, Bronchopulmonary or mediastinal hemorrhage. Patients will be evaluable for AE/DLTs from the start of study therapy through the end of the 3-month observation period

Time frame: 3 months

Secondary Outcomes

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

To assess the feasibility of delivering up to 3 cycles of quad shot palliative radiation therapy to Stage IV NSCLC patients.

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.