Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368329
Status:
TERMINATED
Last Update Posted:
2012-07-16
First Post:
2006-08-22
Brief Title:
Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Phase I Study of Dose Escalation Using Image-guided Radiotherapy to Deliver a Stereotactic Radiosurgical Boost After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Esophageal Cancer
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study the safety and feasibility of stereotactic radiation dose escalation following neoadjuvant chemotherapy with concurrent conventionally fractionated radiation by evaluating the acute and late toxicity of treatment
Detailed Description:
This study will evaluate the safety and feasibility of delivering radiation dose escalation using hypofractionated radiosurgery in locally advanced esophageal cancer The dose escalation will be delivered using an image-guided radiosurgical boost to the tumor volume following a neoadjuvant regimen consisting of oxaliplatin capecitabine and conventionally fractionated radiotherapy In addition we will evaluate the utility of PET-FDG before and after neoadjuvant chemoradiation in predicting the pathologic response to pre-operative treatment We will study the effect of this regimen on pathologic complete response rates and complete resection rates at surgery among patients with locally advanced esophageal cancer and determine patterns of failure and rates of progression-free survival Finally we plan to characterize in an exploratory manner the correlation between molecular markers and pathologic findings following pre-operative chemoradiation
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 |
|---|---|---|---|
| 96075 | OTHER | Stanford University Alternate IRB Number | None |