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A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer, Head and Neck Cancer, Oncology, Squamous Cell Carcinoma

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Trial Information

A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck


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 minor surgery placement, dental extractions, central venous catheter placement, biopsies and nodal
sampling

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy: LRC rate at 2 years

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment

Study ID:

20062079

NCT ID:

NCT00547157

Start Date:

November 2007

Completion Date:

December 2011

Related Keywords:

  • Cancer
  • Head and Neck Cancer
  • Oncology
  • Squamous Cell Carcinoma
  • head and neck
  • squamous cell carcinoma
  • radiotherapy
  • chemoradiotherapy
  • panitumumab
  • locally advanced head & neck cancer
  • EGFr
  • epidermal growth factor receptor
  • SCCHN
  • locally advanced SCCHN
  • HNC
  • epidermal growth factor
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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