Lung Cancer
Conditions
Brief summary
The purpose of this study is to examine the use of hypofractionated accelerated radiation therapy (HART) to treat locally advanced lung cancer. Depending on the location and size of the tumor.
Interventions
RADIATIONHypofractionated accelerated radiation therapy
Hypofractionated accelerated radiation therapy
Sponsors
Stanford University
LUNGevity Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically documented malignancy of the lung including non-small cell lung cancer or small cell lung cancer planned for definitive therapy with fractionated radiation (60-66 Gy) and concurrent systemic therapy * ECOG performance status of 0-2 * Age ≥ 18 years old * Ability to understand and the willingness to personally sign the written IRB approved informed consent document * Estimated life expectancy of 12 weeks or longer
Exclusion criteria
* Contraindication to receiving radiotherapy or systemic therapy as determined by treating radiation and medical oncologist * Age \< 18 years old * Tumor directly invading the major pulmonary arteries, aorta, heart or proximal bronchial tree * Diagnosis of interstitial pulmonary fibrosis * Previous radiation therapy to the thorax that would result in overlapping high dose radiation fields
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting pulmonary and esophageal toxicity | 9 months | Toxicities will be scored by the CTCAE v5.0 criteria. Specific toxicities evaluated are grade 2+ pneumonitis and grade 3+ esophagitis as well as other G3+ pulmonary, esophageal or cardiac toxicities that could be probably or definitely attributed to rT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute and Late Toxicities | 36 months | Patients will be evaluated by the rates of acute and late grade 2+ toxicities including lung, esophageal, cardiac, chest wall, and neurologic. |
| Integrated adaptive dosing regimen with an automated planning system | 36 months | Evaluating the feasibility of integrating an adaptive dosing regimen with an automated planning system with the percentage of automated plans used and the time to plan approval. |
| Progression free survival | 36 months | Determine progression free survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy |
| Overall survival | 36 months | Determine overall survival in patients treated with hypofractionated radiation therapy with concurrent systemic therapy |
| Local control | 36 months | Determine local control in patients treated with hypofractionated radiation therapy with concurrent systemic therapy |
Countries
United States
Contacts
CONTACTAastha Dubey
CONTACTSonya Boyd
PRINCIPAL_INVESTIGATORJoseph A Jaoude, MD
Stanford University
Outcome results
None listed