Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01283178
Status:
TERMINATED
Last Update Posted:
2016-10-31
First Post:
2011-01-24
Brief Title:
Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
A Phase I Dose Escalation Trial Concurrent Intensity-Modulated Radiotherapy IMRT and Chemotherapy With Molecular Image-Guided Adaptive Radiation Therapy IGART for Advanced Head and Neck Squamous Cell Carcinomas HNSCC
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated The data analysis was futile with only 3 accruals PI opted to terminate with IRB and withdraw FDA IND
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue CT and PET scans and treatment-planning systems may help in planning radiation therapy Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving radiation therapy together with cisplatin may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of intensity-modulated image guided adaptive radiation therapy when given together with cisplatin in treating patients with locally advanced head and neck squamous cell cancer
PURPOSE This phase I trial is studying the side effects and best dose of intensity-modulated image guided adaptive radiation therapy when given together with cisplatin in treating patients with locally advanced head and neck squamous cell cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the feasibility of integrating molecular imaging PET with FLT tracer into current state-of-the-art image-guided adaptive radiation therapy IGART of head and neck cancer
II To determine within a predefined range the maximum tolerated radiation dose for concurrent cisplatin and molecular and anatomic image-based IGART of head and neck cancer
SECONDARY OBJECTIVES I To compare gross tumor volumes defined by FDG-PET FLT-PET CBCT and regular FBCT before during and following completion of chemo-radiation therapy
II To evaluate the impact of escalated doses to tumor sub-volumes with high FLT and FDG uptake prior to and during radiation therapy using post-treatment FDG images as an early surrogate for sub-volume-specific local control
III To develop a database consisting of all molecular and anatomic images including daily CBCT data sets obtained during chemo-radiation therapy to support further research Potential applications include determination of optimal adaptive re-planning frequency and the benefits of basing IGART on 4D anatomic data sets derived from deformably registering daily CBCT and FBCT data sets
IV Determine patient long-term toxicities and survival V To evaluate the impact of daily image-guided setup off-line every other week adaptive re-planning and molecular-image based targeting on sparing of tissues and organs responsible for late and early treatment sequelae
OUTLINE This a dose-escalation study of intensity-modulated radiotherapy
Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks Patients also receive cisplatin IV on days 1 and 22 Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 2 and 4 weeks 2 3 4 5 6 9 and 12 months every 6 months for 2 years and then annually for 2 years
I To determine the feasibility of integrating molecular imaging PET with FLT tracer into current state-of-the-art image-guided adaptive radiation therapy IGART of head and neck cancer
II To determine within a predefined range the maximum tolerated radiation dose for concurrent cisplatin and molecular and anatomic image-based IGART of head and neck cancer
SECONDARY OBJECTIVES I To compare gross tumor volumes defined by FDG-PET FLT-PET CBCT and regular FBCT before during and following completion of chemo-radiation therapy
II To evaluate the impact of escalated doses to tumor sub-volumes with high FLT and FDG uptake prior to and during radiation therapy using post-treatment FDG images as an early surrogate for sub-volume-specific local control
III To develop a database consisting of all molecular and anatomic images including daily CBCT data sets obtained during chemo-radiation therapy to support further research Potential applications include determination of optimal adaptive re-planning frequency and the benefits of basing IGART on 4D anatomic data sets derived from deformably registering daily CBCT and FBCT data sets
IV Determine patient long-term toxicities and survival V To evaluate the impact of daily image-guided setup off-line every other week adaptive re-planning and molecular-image based targeting on sparing of tissues and organs responsible for late and early treatment sequelae
OUTLINE This a dose-escalation study of intensity-modulated radiotherapy
Patients undergo intensity-modulated image-guided adaptive radiotherapy once daily 5 days a week for 6 weeks Patients also receive cisplatin IV on days 1 and 22 Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 2 and 4 weeks 2 3 4 5 6 9 and 12 months every 6 months for 2 years and then annually for 2 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-02340 | REGISTRY | None | None |
| P30CA016059 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP30CA016059 |