Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004227
Status:
TERMINATED
Last Update Posted:
2014-02-06
First Post:
2000-01-28
Brief Title:
Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx Hypopharynx or Larynx
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Randomized Phase III Trial to Compare Radiation Therapy Alone With Radiation Therapy and Concomitant Anti-EGFr Antibody C225 for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
Status:
TERMINATED
Status Verified Date:
2012-11
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 Radiation therapy uses high-energy x-rays to damage tumor cells Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells It is not yet known if radiation therapy is more effective with or without cetuximab for cancer of the oropharynx hypopharynx or larynx
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx hypopharynx or larynx
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx hypopharynx or larynx
Detailed Description:
OBJECTIVES
Compare the rate of locoregional disease control maintained for 1 year in patients with advanced squamous cell carcinoma of the oropharynx hypopharynx or larynx treated with radiotherapy with or without concurrent cetuximab
Compare the response rates progression-free survival and overall survival rates and quality of life in patients treated with these regimens
Compare acute and late toxicity of these regimens in these patients
Determine tumor epidermal growth factor receptor levels in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified by Karnofsky performance status 60-80 vs 90-100 nodal stage N0 vs N tumor stage T1-3 vs T4 and radiotherapy schedule concurrent boost vs once daily vs twice daily
Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy beginning on day 1 Patients are assigned to 1 of 3 radiotherapy groups
Group 1 Patients undergo concurrent boost radiotherapy comprised of radiotherapy once daily 5 days a week for 35 weeks followed by radiotherapy twice daily 5 days a week for 25 weeks
Group 2 Patients undergo radiotherapy once daily 5 days a week for 7 weeks
Group 3 Patients undergo radiotherapy twice daily 5 days a week for 6-65 weeks
Arm II Patients receive a test dose of cetuximab IV over 10 minutes on day 1 Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose Patients receive maintenance cetuximab IV over 1 hour on day 8 Maintenance cetuximab repeats every week for 7 courses Beginning on day 8 patients undergo radiotherapy as in arm I concurrently with maintenance cetuximab There must be an hour interval between the completion of cetuximab infusion and the start of any radiotherapy
Patients with more than N1 neck disease at initial presentation undergo neck dissection 4-8 weeks after the completion of radiotherapy
Quality of life is assessed before initiation of study therapy at 8 weeks and then every 4 months for 1 year
Patients are followed at 8 weeks every 4 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 416 patients 208 per arm will be accrued for this study within approximately 5 years
Compare the rate of locoregional disease control maintained for 1 year in patients with advanced squamous cell carcinoma of the oropharynx hypopharynx or larynx treated with radiotherapy with or without concurrent cetuximab
Compare the response rates progression-free survival and overall survival rates and quality of life in patients treated with these regimens
Compare acute and late toxicity of these regimens in these patients
Determine tumor epidermal growth factor receptor levels in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified by Karnofsky performance status 60-80 vs 90-100 nodal stage N0 vs N tumor stage T1-3 vs T4 and radiotherapy schedule concurrent boost vs once daily vs twice daily
Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy beginning on day 1 Patients are assigned to 1 of 3 radiotherapy groups
Group 1 Patients undergo concurrent boost radiotherapy comprised of radiotherapy once daily 5 days a week for 35 weeks followed by radiotherapy twice daily 5 days a week for 25 weeks
Group 2 Patients undergo radiotherapy once daily 5 days a week for 7 weeks
Group 3 Patients undergo radiotherapy twice daily 5 days a week for 6-65 weeks
Arm II Patients receive a test dose of cetuximab IV over 10 minutes on day 1 Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose Patients receive maintenance cetuximab IV over 1 hour on day 8 Maintenance cetuximab repeats every week for 7 courses Beginning on day 8 patients undergo radiotherapy as in arm I concurrently with maintenance cetuximab There must be an hour interval between the completion of cetuximab infusion and the start of any radiotherapy
Patients with more than N1 neck disease at initial presentation undergo neck dissection 4-8 weeks after the completion of radiotherapy
Quality of life is assessed before initiation of study therapy at 8 weeks and then every 4 months for 1 year
Patients are followed at 8 weeks every 4 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL Approximately 416 patients 208 per arm will be accrued for this study within approximately 5 years
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 |
|---|---|---|---|
| NCI-G99-1657 | None | None | None |
| UAB-9901 | None | None | None |
| IMCL-CP02-9815 | None | None | None |