Status:

TERMINATED

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

Lead Sponsor:

West Virginia University

Conditions:

Non-small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 w...

Eligibility Criteria

Inclusion

  • Stage II - III Non Small Cell Lung Cancer

Exclusion

  • 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.

Key Trial Info

Start Date :

July 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2017

Estimated Enrollment :

1 Patients enrolled

Trial Details

Trial ID

NCT02252796

Start Date

July 1 2014

End Date

September 1 2017

Last Update

May 30 2018

Active Locations (1)

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Page 1 of 1 (1 locations)

1

West Virginia University Hospitals Mary Babb Randolph Cancer Center

Morgantown, West Virginia, United States, 26506