Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084318
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2004-06-10
Brief Title:
Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck
Status:
COMPLETED
Status Verified Date:
2016-12
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 Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy such as cisplatin and docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy Combining a monoclonal antibody with chemoradiotherapy and giving them after surgery may kill any remaining tumor cells
PURPOSE This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma cancer or lymphoepithelioma of the head and neck
PURPOSE This randomized phase II trial is studying adjuvant cetuximab given together with chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab given together with chemoradiotherapy using docetaxel in treating patients with resected stage III or stage IV squamous cell carcinoma cancer or lymphoepithelioma of the head and neck
Detailed Description:
OBJECTIVES
Primary
Compare disease-free survival of patients with resected stage III or IV squamous cell carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in combination with chemoradiotherapy comprising docetaxel vs cisplatin
Secondary
Compare the safety and efficacy of these regimens in these patients
Compare locoregional control and overall survival rates in patients treated with these regimens
Correlate epidermal growth factor receptor total and phosphorylated pMAPK pAKT Stat-3 Ki-67 cyclo-oxygenase-2 and cyclin B1 expression with outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to Zubrod performance status 0 vs 1 risk category positive margins vs high risk ie 2 positive nodes or extracapsular nodal extension and use of intensity-modulated radiotherapy no vs yes Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cetuximab IV over 2 hours on day 1 week 1 Patients then receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on days 8 15 22 29 36 and 43 weeks 2-7 Patients undergo radiotherapy once daily 5 days a week beginning on day 8 for a total of 6 weeks weeks 2-7
Arm II Patients receive cetuximab and undergo radiotherapy as in arm I Patients also receive docetaxel IV over 30 minutes before radiotherapy on days 8 15 22 29 36 and 43 weeks 2-7
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 230 patients 115 per treatment arm will be accrued for this study within approximately 29 months
Primary
Compare disease-free survival of patients with resected stage III or IV squamous cell carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in combination with chemoradiotherapy comprising docetaxel vs cisplatin
Secondary
Compare the safety and efficacy of these regimens in these patients
Compare locoregional control and overall survival rates in patients treated with these regimens
Correlate epidermal growth factor receptor total and phosphorylated pMAPK pAKT Stat-3 Ki-67 cyclo-oxygenase-2 and cyclin B1 expression with outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to Zubrod performance status 0 vs 1 risk category positive margins vs high risk ie 2 positive nodes or extracapsular nodal extension and use of intensity-modulated radiotherapy no vs yes Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cetuximab IV over 2 hours on day 1 week 1 Patients then receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on days 8 15 22 29 36 and 43 weeks 2-7 Patients undergo radiotherapy once daily 5 days a week beginning on day 8 for a total of 6 weeks weeks 2-7
Arm II Patients receive cetuximab and undergo radiotherapy as in arm I Patients also receive docetaxel IV over 30 minutes before radiotherapy on days 8 15 22 29 36 and 43 weeks 2-7
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 230 patients 115 per treatment arm will be accrued for this study within approximately 29 months
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 |
|---|---|---|---|
| CDR0000360850 | None | None | None |