Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT01302834
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2011-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Study Overview
Official Title:
Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Status:
COMPLETED
Status Verified Date:
2025-09
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 kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer.
PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.
PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.
Detailed Description:
OBJECTIVES:
Primary
* To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival.
Secondary
* To monitor and compare progression-free survival for "safety".
* To compare patterns of failure (locoregional vs distant).
* To compare acute toxicity profiles (and overall toxicity burden).
* To compare overall quality of life (QOL) short-term (\< 6 months) and long-term (1 year).
* To compare QOL Swallowing Domains short-term and long-term.
* To compare clinician-reported versus patient-reported CTCAE toxicity events.
* To explore differences in the cost effectiveness of cetuximab as compared to cisplatin.
* To explore differences in work status and time to return to work.
* To compare patient-reported changes in hearing.
* To compare CTCAE v. 4 late toxicity at 1, 2, and 5 years.
* To evaluate the effect of tobacco exposure (and other exposures) as measured by standardized computer-assisted self interview (CASI) on overall survival and progression-free survival.
* To pilot CASI collection of patient reported outcomes in a cooperative group setting.
* To determine whether specific molecular profiles are associated with overall or progression-free survival.
* To investigate associations between changes in serum biomarkers or human papilloma virus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival.
OUTLINE: This is a multicenter study. Patients are stratified according to T stage (T1-2 vs T 3-4), N stage (N0-2a vs N2b-3), Zubrod performance status (0 vs 1), and smoking history (≤ 10 pack-years vs \> 10 pack-years). Patients are randomized to 1 of 2 treatment arms.
Patients may complete quality-of-life questionnaires and risk factors for head and neck cancer surveys at baseline, periodically during study, and at follow-up for 1 year.
After completion of study therapy, patients are followed up at 1-3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Primary
* To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival.
Secondary
* To monitor and compare progression-free survival for "safety".
* To compare patterns of failure (locoregional vs distant).
* To compare acute toxicity profiles (and overall toxicity burden).
* To compare overall quality of life (QOL) short-term (\< 6 months) and long-term (1 year).
* To compare QOL Swallowing Domains short-term and long-term.
* To compare clinician-reported versus patient-reported CTCAE toxicity events.
* To explore differences in the cost effectiveness of cetuximab as compared to cisplatin.
* To explore differences in work status and time to return to work.
* To compare patient-reported changes in hearing.
* To compare CTCAE v. 4 late toxicity at 1, 2, and 5 years.
* To evaluate the effect of tobacco exposure (and other exposures) as measured by standardized computer-assisted self interview (CASI) on overall survival and progression-free survival.
* To pilot CASI collection of patient reported outcomes in a cooperative group setting.
* To determine whether specific molecular profiles are associated with overall or progression-free survival.
* To investigate associations between changes in serum biomarkers or human papilloma virus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival.
OUTLINE: This is a multicenter study. Patients are stratified according to T stage (T1-2 vs T 3-4), N stage (N0-2a vs N2b-3), Zubrod performance status (0 vs 1), and smoking history (≤ 10 pack-years vs \> 10 pack-years). Patients are randomized to 1 of 2 treatment arms.
Patients may complete quality-of-life questionnaires and risk factors for head and neck cancer surveys at baseline, periodically during study, and at follow-up for 1 year.
After completion of study therapy, patients are followed up at 1-3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study Oversight
Has Oversight DMC:
True
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?: