Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
West Virginia University
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Stage II - III Non Small Cell Lung Cancer
You may not be if
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.
Clareo Health | Phase I Hypofractionated Stereotactic Boost (Radiotherapy) for Non-Small Cell Lung Cancer