Lung Cancer
Conditions
Brief summary
The purpose of this study is to see whether designing radiation to spare the vertebral bone marrow can limit the rates of lymphopenia during standard of care chemoradiation therapy and in the time to count recovery in the ensuing weeks. Secondary endpoints will examine whether this leads to improved disease control whether this is predictive of improved clinical outcomes such as rates of local recurrence (LR), metastasis free survival (MFS), overall survival (OS), and progression free survival (PFS) which will be followed prospectively up to 5 years.
Interventions
OTHEREvidence-based radiation dose limitation to the vertebral bone marrow
The only intervention that will occur during the radiation treatment planning process will be the application of evidence-based radiation dose limitations to the vertebral bone marrow during treatment plan optimization in order to attempt to limit Grade 3 Lymphopenia (G3L) toxicity.
Sponsors
The University of Texas Health Science Center at San Antonio
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
* Adult patient \> 18 years * Patients with AJCC (American Joint Committee on Cancer) 8 T1-T4, N1-N3, M0 stage IIIA-IIIC NSCLC (non small cell lung cancer) * Patients with oligometastatic disease stage IV, M1 disease, in which definitive concurrent chemoradiotherapy to the thorax is planned * CBC/CMP within these limits * Absolute lymphocyte count\>500/ml * Hemoglobin\>8 g/dL * AST (aspartate aminotransferase)/ALT (alanine transaminase) \<2.5 times of ULN * Eastern Cooperative Oncology Group (ECOG) 0-2
Exclusion criteria
* History of thoracic irradiation * History of palliative radiation for the current malignancy under consideration * Patients not being treated with definitive standard of care to the chest * History of bone marrow disease and or leukemia * History of prior cytotoxic chemotherapy for a disease other than for the current malignancy * Polymetastatic disease, defined here as ≥3 or more extrathoracic metastases * Administration of concurrent immunotherapy during radiation therapy, either as part of another clinical trial or otherwise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limited G3L Toxicity | 6 weeks | The primary end point will be evaluating whether implementing dosimetric constraints to the bone marrow will decrease rates of G3L toxicity in the peripheral blood compared to expected rates of 40% in large series examining toxicities during chemoradiation. Values will be expressed as a percentage rates of G3L lymphopenia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Baseline to study end (up to 5 years) | Overall Survival (OS), as measured from time of enrollment in the study |
| Progression free Survival (PFS) | Baseline to study end (up to 5 years) | Progression Free Survival (PFS), either distant or local measured on routine surveillance imaging |
| Local Recurrence (LR) | Baseline to study end (up to 5 years) | Local Recurrence (LR), measured per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on routine imaging, |
| Metastasis Free Survival (MFS) | Baseline to study end (up to 5 years) | Metastasis Free Survival (MFS), as measured on surveillance imaging |
| Change in Neutrophil to Lymphocyte ratio (NLR) | Baseline to study end (up to 5 years) | — |
Countries
United States
Outcome results
None listed