Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-29 @ 11:20 AM
Study NCT ID:
NCT02388932
Status:
TERMINATED
Last Update Posted:
2019-01-24
First Post:
2015-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Phase I Dose Escalation Study of Stereotactic Body Radiotherapy for Carcinoma of the Head and Neck in High Risk Patients Who Are Ineligible/Refuse Standard of Care Therapy
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow 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 stereotactic body radiation therapy (SBRT) in treating participants with head and neck cancer that has spread from where it started to nearby tissue or lymph nodes and is at high risk for continuing to spread because the participant cannot undergo standard chemotherapy. Stereotactic body radiation therapy is a specialized radiation therapy that delivers radiation directly to the tumor in smaller doses over several days, which may kill more tumor cells and cause less damage to normal tissue.
Detailed Description:
PRIMARY OBJECTIVES:
I. To explore the maximum tolerated dose of head and neck stereotactic body radiation therapy (SBRT) in a high risk participant population ineligible for standard chemoradiotherapy.
SECONDARY OBJECTIVES:
I. Assess profiles of SBRT toxicity and examine participant (including co-morbidities), tumor and treatment related factors that are associated with SBRT related toxicity.
II. Identify any dose volume parameters that are associated with SBRT related toxicity.
III. Explore potential dose response relationships between higher SBRT dosing and radiographic response.
IV. Assess impact of SBRT on participants' quality of life.
OUTLINE: This is a dose-escalation study.
Participants undergo SBRT in 5 fractions at least 40 hours apart over 10-18 days.
After completion of study treatment, participants are followed up at 0.5, 3, 6, 9, and 12 months.
I. To explore the maximum tolerated dose of head and neck stereotactic body radiation therapy (SBRT) in a high risk participant population ineligible for standard chemoradiotherapy.
SECONDARY OBJECTIVES:
I. Assess profiles of SBRT toxicity and examine participant (including co-morbidities), tumor and treatment related factors that are associated with SBRT related toxicity.
II. Identify any dose volume parameters that are associated with SBRT related toxicity.
III. Explore potential dose response relationships between higher SBRT dosing and radiographic response.
IV. Assess impact of SBRT on participants' quality of life.
OUTLINE: This is a dose-escalation study.
Participants undergo SBRT in 5 fractions at least 40 hours apart over 10-18 days.
After completion of study treatment, participants are followed up at 0.5, 3, 6, 9, and 12 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-02279 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CASE8314 | None | None | View | |
| CASE 8314 | OTHER | Case Comprehensive Cancer Center | View | |
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |