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

Non-small Cell Lung Cancer Clinical Trial

— HySBst  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02252796
• Other study ID #: WVU020513
• Status: Terminated
• Phase: Phase 1
• Start date: July 2014
• Est. completion date: September 2017

Study information

• Verified date: May 2018
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.
• Paclitaxel
Given during chemo-radiation phase and optional consolidative phase.

Radiation:
• Image-guided IMRT
Given during chemo-radiation phase

Locations

Country	Name	City	State
United States	West Virginia University Hospitals Mary Babb Randolph Cancer Center	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose of HySBst		2 years
Secondary	Dose Limiting Toxicity		1 week
Secondary	Blood Sample Collection	Biomarker analysis	2 years
Secondary	Local Control	To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)	2 years
Secondary	Quality of Life	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	2 years