Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments hypofractionated stereotactic boost, carboplatin, paclitaxel, image-guided imrt
Phase phase 1
Sponsor West Virginia University
Start date July 2014
End date December 2017
Trial size 18 participants
Trial identifier NCT02252796, WVU020513

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
hypofractionated stereotactic boost HySBst
An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.
carboplatin
Given during chemo-radiation phase and optional consolidative phase.
paclitaxel
Given during chemo-radiation phase and optional consolidative phase.
image-guided imrt
Given during chemo-radiation phase
(Experimental)
Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
hypofractionated stereotactic boost HySBst
An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.
carboplatin
Given during chemo-radiation phase and optional consolidative phase.
paclitaxel
Given during chemo-radiation phase and optional consolidative phase.
image-guided imrt
Given during chemo-radiation phase

Primary Outcomes

Measure
Maximum Tolerated Dose of HySBst
time frame: 2 years

Secondary Outcomes

Measure
Dose Limiting Toxicity
time frame: 1 week
Blood Sample Collection
time frame: 2 years
Local Control
time frame: 2 years
Quality of Life
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Principal investigator Malcolm Mattes, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by West Virginia University.