Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-03-04 @ 11:54 PM
Study NCT ID:
NCT02059967
Status:
WITHDRAWN
Last Update Posted:
2015-03-19
First Post:
2014-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
A Phase I Image-Guided Adaptive Radiotherapy Study Using Active Breathing Control (ABC) and Simultaneous Integrated Boost for Patients With Inoperable Non-Small Cell Lung Cancer
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to no accrual.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and best dose of image-guided adaptive radiation therapy using active breathing control when given together with chemotherapy and simultaneous integrated boost in treating patients with stage IIA-IIIB non-small cell lung cancer that cannot be removed by surgery. Image-guided adaptive radiation therapy aims radiation therapy right at the tumor so that higher radiation doses can be given without causing bad side effects. Giving these higher doses may help control the tumor better. Breathing causes organs and tissues, including the tumor, to move within the chest. Active breathing control may reduce the volume that needs to be treated. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving image-guided adaptive radiation therapy using active breathing control with chemotherapy and simultaneous integrated boost may be an effective treatment for non-small cell lung cancer.
Detailed Description:
OUTLINE: This is a dose-escalation study of IGART.
Patients undergo IGART using active breathing control (ABC) 5 days a week for 7 weeks, for a total of 33 fractions with simultaneous integrated volume adapted boost (SIVAB) during fractions 26-33. Patients also receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.
After completion of study treatment, patients are followed up periodically for 5 years.
Patients undergo IGART using active breathing control (ABC) 5 days a week for 7 weeks, for a total of 33 fractions with simultaneous integrated volume adapted boost (SIVAB) during fractions 26-33. Patients also receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.
After completion of study treatment, patients are followed up periodically for 5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: