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

Phase 1

Terminated

• Conditions: Non-small Cell Lung Cancer
• Interventions: Radiation: Hypofractionated Stereotactic Boost; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Image-guided IMRT

• Registration Number: NCT02252796
• Lead Sponsor: West Virginia University

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-30
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sub-group 2	Hypofractionated Stereotactic Boost	Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
Sub-group 2	Image-guided IMRT	Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
Sub-group 1	Hypofractionated Stereotactic Boost	HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
Sub-group 1	Carboplatin	HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
Sub-group 1	Image-guided IMRT	HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
Sub-group 1	Paclitaxel	HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
Sub-group 2	Paclitaxel	Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
Sub-group 2	Carboplatin	Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose of HySBst	2 years

Secondary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	1 week
Blood Sample Collection	2 years	Biomarker analysis
Local Control	2 years	To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)
Quality of Life	2 years	To determine the quality of life before and after treatment using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 and Lung Cancer 13 (EORTC QLQ-C30, and the LC 13) scales

Trial Locations

Locations (1)

West Virginia University Hospitals Mary Babb Randolph Cancer Center; 🇺🇸 Morgantown, West Virginia, United States