NCT02252796

Phase I Hypofractionated Stereotactic Boost (Radiotherapy) for Non-Small Cell Lung Cancer

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Hypofractionated Stereotactic Boost	An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.
DRUG	Carboplatin	Given during chemo-radiation phase and optional consolidative phase.
DRUG	Paclitaxel	Given during chemo-radiation phase and optional consolidative phase.
RADIATION	Image-guided IMRT	Given during chemo-radiation phase

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2014-09-30
• Last updated: 2018-05-30

Locations

1 site across 1 country: United States