Expired Study
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Morgantown, West Virginia 26506


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02252796


Primary Contact:

Principal Investigator
Malcolm Mattes, MD
West Virginia University - Mary Babb Randolph Cancer Center


Backup Contact:

N/A


Location Contact:

Morgantown, West Virginia 26506
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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