Phase I Dose Escalation Study of a Hypofractionated Stereotactic Boost (HySBst) to the Primary Site in Patients With Stage II-III Non-small Cell Lung Cancer
Overview
- Phase
- Phase 1
- Intervention
- Hypofractionated Stereotactic Boost
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- West Virginia University
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose of HySBst
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
Sub-group 1
HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
Intervention: Hypofractionated Stereotactic Boost
Sub-group 1
HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
Intervention: Carboplatin
Sub-group 1
HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
Intervention: Paclitaxel
Sub-group 1
HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
Intervention: Image-guided IMRT
Sub-group 2
Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
Intervention: Hypofractionated Stereotactic Boost
Sub-group 2
Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
Intervention: Carboplatin
Sub-group 2
Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
Intervention: Paclitaxel
Sub-group 2
Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
Intervention: Image-guided IMRT
Outcomes
Primary Outcomes
Maximum Tolerated Dose of HySBst
Time Frame: 2 years
Secondary Outcomes
- Dose Limiting Toxicity(1 week)
- Blood Sample Collection(2 years)
- Local Control(2 years)
- Quality of Life(2 years)