Ignite Creation Date:
2024-05-06 @ 12:41 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01634880
Status:
WITHDRAWN
Last Update Posted:
2016-05-23
First Post:
2012-07-03
Brief Title:
Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies
Sponsor:
Athanassios Argiris
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Phase II Trial of Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies
Status:
WITHDRAWN
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Standard therapy for high-risk or locally advanced salivary gland malignancies is surgery followed by postoperative radiation therapy Studies have shown the superiority of combined modality therapy compared to surgery alone Despite the addition of postoperative radiation therapy the five-year survival for locally advanced salivary gland malignancies is poor less than 60 In salivary gland malignancies the epidermal growth factor receptor EGFR is expressed in 25-85 in certain histological types like salivary duct carcinomas the expression is higher EGFR is a promising target of anticancer therapy In squamous cell carcinoma of the head and neck a phase III trial utilizing cetuximab added to radiation therapy improved both locoregional control and overall survival compared to radiation alone Panitumumab is a novel human IgG2 EGFR monoclonal antibody that may be better tolerated and more efficacious than cetuximab Here the investigators hypothesize that the addition of panitumumab to standard radiotherapy in locally advanced salivary gland malignancies will improve recurrence-free survival RFS
Detailed Description:
Specific Aims To determine the recurrence-free survival primary endpoint overall survival local and distant recurrence-free survival and treatment-related toxicities Also the investigators plan to study EGFR-related and immune biomarkers in baseline tumor tissue as well as blood samples obtained prior and after therapy
Subject Population We will enroll patients with completely resected locally advanced salivary gland cancers
Treatment Plan Standard radiation 64-70Gy with 20 Gy daily fractions in 6-7 weeks Panitumumab 25 mgKg IV weekly during radiation total of 6-7 doses
Statistical Design and Sample Size Phase II one-stage study with the 3-year recurrence-free survival RFS as the primary endpoint The sample size is 30 patients
Subject Population We will enroll patients with completely resected locally advanced salivary gland cancers
Treatment Plan Standard radiation 64-70Gy with 20 Gy daily fractions in 6-7 weeks Panitumumab 25 mgKg IV weekly during radiation total of 6-7 doses
Statistical Design and Sample Size Phase II one-stage study with the 3-year recurrence-free survival RFS as the primary endpoint The sample size is 30 patients
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 |
|---|---|---|---|
| HSC20120130H | OTHER | UTHSCSA IRB | None |