Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369512
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-08-24
Brief Title:
A Trial of Erlotinib Radiotherapy for Cutaneous Squamous Cell Carcinoma
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Phase II Trial of Erlotinib and Radiotherapy in Patients With Stage III Cutaneous Squamous Cell Carcinomas
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAD0503
Brief Summary:
This is a phase II study designed to study the effectiveness of combined radiotherapy and erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk for recurrence Participants enrolled in the study will be evaluated by a head and neck surgeon and a radiation oncologist Whenever possible a preoperative biopsy will be performed after participant enrollment in the study for histological confirmation and for molecular correlates Participants enrolled prior to surgical resection will begin erlotinib at 150 mg by mouth PO every day QD 14 tablets to be taken 14 days prior to surgical resection Following planned surgical resection the participant will begin Erlotinib therapy and radiotherapy at the same time and within 4-8 weeks of the surgical resection
Detailed Description:
This is a single-institution open-label non-randomized phase II trial of erlotinib administered concomitantly with radiation therapy following surgical resection of gross disease A total of 45 patients with previously unirradiated high-risk cutaneous SCC requiring post-operative radiotherapy will be enrolled to assess the primary endpoints of time to recurrence and disease free survival Pretreatment biopsies will be required to confirm the histological diagnosis of SCC Four to six weeks after surgical resection patients will begin erlotinib 150 mg po qd beginning the first day of radiotherapy Patients will receive 5040 cGy beginning on day 1 of therapy in standard fractionations Patients will be followed to evaluate for toxicity based on NCI common toxicity criteria v30 Patients will be followed on protocol for a minimum of 2 years with regularly scheduled CT scans clinical evaluations and laboratory work Patients with residual or recurrent cancer will be taken off protocol for salvage therapy
As a secondary objective molecular response of tumors to erlotinib monotherapy will be determined When possible participants will be enrolled and treated for 14 days with erlotinib prior to surgical resection The pretreatment biopsy specimen control will then be compared to tissue acquired during the surgical resection after 14 days of erlotinib experimental group
As a secondary objective molecular response of tumors to erlotinib monotherapy will be determined When possible participants will be enrolled and treated for 14 days with erlotinib prior to surgical resection The pretreatment biopsy specimen control will then be compared to tissue acquired during the surgical resection after 14 days of erlotinib experimental group
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