Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054561
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2003-02-05
Brief Title:
Isotretinoin Interferon Alfa and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase III Randomized Study of Adjuvant Biologic Therapy in Patients With Stages IIIIV Head and Neck Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2023-06
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as isotretinoin use different ways to stop tumor cells from dividing so they stop growing or die Interferon alfa may interfere with the growth of tumor cells Vitamin E may be able to decrease side effects caused by isotretinoin It is not yet known whether combining isotretinoin and interferon alfa with vitamin E is more effective than observation in preventing recurrence of head and neck cancer after surgery andor radiation therapy
PURPOSE Randomized phase III trial to compare the effectiveness of isotretinoin and interferon alfa combined with vitamin E with that of observation in treating patients who have undergone surgery andor radiation therapy for stage III or stage IV head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of isotretinoin and interferon alfa combined with vitamin E with that of observation in treating patients who have undergone surgery andor radiation therapy for stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of adjuvant isotretinoin interferon alfa and vitamin E in terms of incidence of primary disease recurrence and secondary primary tumor development in patients with stage III or IV squamous cell carcinoma of the head and neck previously treated with definitive surgical excision andor postoperative radiotherapy
Determine the qualitative and quantitative toxicity of this regimen in these patients
Compare the overall and disease-free survival of patients treated with this regimen vs those who undergo observation only
Determine whether alterations of p53 gene retinoic acid receptors retinoid-regulated gene and interferon-responsive genes are associated with clinical outcome in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to T stage T1 or T2 vs T3 or T4 N stage N0 or N1 vs N2 or N3 prior therapy complete tumor resection vs resection and radiotherapychemoradiotherapy vs radiotherapy or chemoradiotherapy alone and prior chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral isotretinoin once daily interferon alfa subcutaneously 3 times weekly and oral vitamin E 3 times daily Treatment repeats every month for 12 courses 1 year in the absence of disease recurrence or unacceptable toxicity
Arm II Patients undergo observation only for 1 year Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 376 patients 188 per treatment arm will be accrued for this study within 375 years
Determine the efficacy of adjuvant isotretinoin interferon alfa and vitamin E in terms of incidence of primary disease recurrence and secondary primary tumor development in patients with stage III or IV squamous cell carcinoma of the head and neck previously treated with definitive surgical excision andor postoperative radiotherapy
Determine the qualitative and quantitative toxicity of this regimen in these patients
Compare the overall and disease-free survival of patients treated with this regimen vs those who undergo observation only
Determine whether alterations of p53 gene retinoic acid receptors retinoid-regulated gene and interferon-responsive genes are associated with clinical outcome in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to T stage T1 or T2 vs T3 or T4 N stage N0 or N1 vs N2 or N3 prior therapy complete tumor resection vs resection and radiotherapychemoradiotherapy vs radiotherapy or chemoradiotherapy alone and prior chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral isotretinoin once daily interferon alfa subcutaneously 3 times weekly and oral vitamin E 3 times daily Treatment repeats every month for 12 courses 1 year in the absence of disease recurrence or unacceptable toxicity
Arm II Patients undergo observation only for 1 year Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 376 patients 188 per treatment arm will be accrued for this study within 375 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| ECOG-1301 | None | None | None |