Non-small Cell Lung Cancer
Conditions
Keywords
Non-small Cell Lung Cancer, Radiotherapy Therapy
Brief summary
This study will help researchers test the safety of hypofractionated dose of radiotherapy (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung Cancer.
Detailed description
Patients are assigned to Sub-group 1 or 2 based on the primary lesion size and location. This protocol will utilize a standard 3 + 3 phase I design with three patients enrolled per cohort. Patients will be offered the opportunity to participate in the blood specimen component of the study. Patients will be followed up to 2 years post radiation therapy. Sub-group 1 will receive HySBst for 1 week. Weeks 2-7 will be standard chemo-radiation therapy. Patients have the option of consolidative chemotherapy at week 12. Sub-group 2 will receive standard chemo-radiation therapy for weeks 1-6 then receive HySBst during week 7. Patients have the option of consolidative chemotherapy at week 12. HySBst dose escalation for each sub-group is listed below: Optional: 4 Gy x 4 daily fractions Level 1: 5 Gy x 4 daily fractions Level 2: 5.5 Gy x 4 daily fractions Level 3: 6 Gy x 4 daily fractions DLTs will be based on events occurring during the course of HySBst. Chemo-Radiation Therapy is defined as: Standard Carboplatin & Paclitaxel Doublelet Regimen with weekly Carboplatin AUC 2/week and Paclitaxel 45 mg/ m2/ week during conventionally fractionated IMRT Image-guided IMRT to 60 Gy, 5 x per week for 6 weeks Consolidative chemotherapy is defined as Carboplatin AUC 6 and Paclitaxel 200 mg/m2 every 21 days x 2 cycles will be given after ALL radiotherapy is delivered.
Interventions
RADIATIONHypofractionated Stereotactic Boost
An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.
DRUGCarboplatin
Given during chemo-radiation phase and optional consolidative phase.
DRUGPaclitaxel
Given during chemo-radiation phase and optional consolidative phase.
RADIATIONImage-guided IMRT
Given during chemo-radiation phase
Sponsors
West Virginia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage II - III Non Small Cell Lung Cancer
Exclusion criteria
* Primary tumor directly invading into any mediastinal structures, such as the heart, major blood vessels, esophagus, trachea, and the proximal bronchial tree. * Prior chemotherapy for NSCLC * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. * Severe, active co-morbidity * Pregnancy or women of childbearing potential * Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin * Uncontrolled neuropathy ≥ grade 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose of HySBst | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Sample Collection | 2 years | Biomarker analysis |
| Dose Limiting Toxicity | 1 week | — |
| Local Control | 2 years | To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS) |
| Quality of Life | 2 years | To determine the quality of life before and after treatment using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 and Lung Cancer 13 (EORTC QLQ-C30, and the LC 13) scales |
Countries
United States
Outcome results
None listed