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Study Complete
Sponsor ID
20062079

Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy with Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Sponsor ID
20062079
Clinicaltrials.gov ID
NCT00547157
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.

Additional Study Details

Phase
Phase 2
Product
panitumumab
Type
Interventional
Masking
None (Open Label)
Enrollment
152
Additional Study Details

Protocol Summary

Primary Outcome Measures

Efficacy: LRC rate at 2 years

Timeframe: 2 years

Secondary Outcome Measures

Efficacy: PFS, OS, duration of LRC, LRC at 6 months and 1 year, rate of CR by 6 months, ORR by 6 months. Safety: Incidence of early death (on or within 30 days of last protocol-defined treatment)

Timeframe: LRC at 6 months and 1 year, rate of CR by 6 months, ORR by 6 months

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Cancer - Other
    • Show more
  • Head and Neck Cancer
    • Sex
    All
    Trial Dates
    Nov 2007 - Dec 2011
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Histologically or cytologically confirmed SCC of the oral cavity, oropharynx, hypopharynx or larynx Stage III or Stage IVa-b (M0) disease according to the American Joint Committee on Cancer staging manual 6th edition (locally advanced) ECOG performance status of 0 or 1 Bidimensionally measurable disease >/= 10 mm in at least 1 dimension
    Exclusion Criteria:
    NO Primary tumor of the nasopharynx, sinuses, salivary gland, or skin NO Subjects requiring prophylactic tracheostomy NO Prior (or concomitant) malignancy (except non-melanomatous skin cancer or in situ cervical cancer), other than the study disease (SCCHN), unless treated with curative intent with no evidence of disease for >/= 3 years NO Prior treatment for locally advanced SSCHN NO Prior surgery for SCCHN (except nodal sampling or biopsy for study disease) NO Major surgery