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

NCT02252796 | Terminated Phase 1 DMC

• 1 other identifier: WVU020513
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer; Radiotherapy Therapy

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of HySBst

  2 years

Secondary Outcomes (4)

• Dose Limiting Toxicity

  1 week

• Blood Sample Collection

  2 years

• Local Control

  2 years

• Quality of Life

  2 years

Study Arms (2)

Sub-group 1

EXPERIMENTAL

HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7

Radiation: Hypofractionated Stereotactic Boost; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Image-guided IMRT

Sub-group 2

EXPERIMENTAL

Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7

Radiation: Hypofractionated Stereotactic Boost; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Image-guided IMRT

Interventions

Hypofractionated Stereotactic Boost RADIATION

An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.

Also known as: HySBst

Sub-group 1; Sub-group 2

Carboplatin DRUG

Given during chemo-radiation phase and optional consolidative phase.

Sub-group 1; Sub-group 2

Paclitaxel DRUG

Given during chemo-radiation phase and optional consolidative phase.

Sub-group 1; Sub-group 2

Image-guided IMRT RADIATION

Given during chemo-radiation phase

Sub-group 1; Sub-group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage II - III Non Small Cell Lung Cancer

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Hospitals Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Malcolm Mattes, MD

  West Virginia University - Mary Babb Randolph Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 30, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)