Non-Small Cell Lung Cancer
Conditions
Keywords
Cyclical Hypofractionated Palliative Radiation (Quad Shot, 20-148
Brief summary
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.
Interventions
RADIATIONCyclical Hypofractionated Palliative Radiation (Quad Shot)
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.
BEHAVIORALEORTC QLQ-C30 questionnaire
at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase I, prospective trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who are able to complete the assigned radiation therapy regimen (3 cycles of quad shot) | 1 year | To assess the feasibility of delivering up to 3 cycles of quad shot palliative radiation therapy to Stage IV NSCLC patients. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer Ma, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed