Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer
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.
Head and Neck Cancer
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer|
- 5-year overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Local-regional failure [ Designated as safety issue: No ]
- Distant metastasis [ Designated as safety issue: No ]
- Acute toxicities (CTCAE v. 4) and overall toxicity burden at end of treatment and at 1, 3, and 6 months after completion of treatment [ Designated as safety issue: Yes ]
- Late toxicities (CTCAE v. 4) at 1, 2, and 5 years [ Designated as safety issue: Yes ]
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||June 2020 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients undergo image-guided intensity-modulated radiation therapy (IMRT) once daily on days 1-4 and twice daily on day 5 weekly for 6 weeks. Patients also receive high-dose cisplatin IV over 1-2 hours on days 1 and 22.
Active Comparator: Arm II
Beginning 1 week prior to IMRT, patients receive cetuximab IV over 2 hours. Patients then receive cetuximab IV over 1 hour once weekly for 7 weeks. Patients undergo IMRT as in arm I.
- To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival.
- 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 (2 years).
- 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 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.
- Arm I: Patients undergo image-guided intensity-modulated radiation therapy (IMRT) once daily on days 1-4 and twice daily on day 5 weekly for 6 weeks. Patients also receive high-dose cisplatin IV over 1-2 hours on days 1 and 22.
- Arm II: Beginning 1 week prior to IMRT, patients receive cetuximab IV over 2 hours. Patients then receive cetuximab IV over 1 hour once weekly for 7 weeks. Patients undergo IMRT as in arm I.
Tumor tissue and blood samples are collected at baseline and may also be collected at 3- and 6-month follow-up visits for correlative studies.
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.
Show 185 Study Locations
|Principal Investigator:||Andy M. Trotti, MD||H. Lee Moffitt Cancer Center and Research Institute|