Study Complete
Sponsor ID
20062080

Study of Addition of Panitumumab to Chemoradiation Therapy in Patients with Locally Advanced Head and Neck Cancer

Sponsor ID
20062080
Clinicaltrials.gov ID
NCT00500760
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. The study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.

Additional Study Details

Phase
Phase 2
Product
panitumumab
Type
Interventional
Masking
None (Open Label)
Enrollment
153
Additional Study Details

Protocol Summary

Primary Outcome Measures

Local-regional control rate

Timeframe: at two years

Secondary Outcome Measures

Exploratory (to investigate potential biomarker development)

Timeframe: Blood samples for biomarker development will be collected until 60 days post completion of radiotherapy. Archived or fresh paraffin-embedded tumor tissue will be collected at anytime during the study

Progression-free survival, overall survival and duration of local-regional control

Timeframe: Subjects will be followed for at least 2 years from randomisation until end of study

Local-regional control rate

Timeframe: at 6 months and 1 year

Overall response rate

Timeframe: by 6 months

Complete response rate

Timeframe: by 6 months

Safety and Quality of Life

Timeframe: Subjects will be followed for at least 2 years from randomisation until end of study

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.