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Clinical Trials/EUCTR2010-019071-29-GB
EUCTR2010-019071-29-GB
Active, not recruiting
Not Applicable

A Phase 3 Randomized Trial of Concurrent Cisplatin And Radiotherapy With or Without OncoVEXGM-CSF in Previously Untreated Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

BioVex, Inc.0 sites580 target enrollmentMarch 29, 2010
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
BioVex, Inc.
Enrollment
580
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 29, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female \= 18 years.
  • •2\. ECOG Performance Status \= 1\.
  • •3\. Histological evidence (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
  • •4\. Stage III or IV disease (T2N2\-3M0, T3\-4 N1\-3 M0\).
  • •5\. No evidence of distant metastases by CT or PET/CT scan.
  • •6\. Life expectancy \= 4 months.
  • •7\. Neutrophil count \= 2,000/mm^3\.
  • •8\. Platelet count \= 100,000/mm^3\.
  • •9\. Hemoglobin \= 10 g/dL.
  • •10\. Bilirubin \= 1\.5 times ULN s.

Exclusion Criteria

  • •1\. Prior treatment for locally advanced SCCHN (NO prior surgery for SCCHN except
  • •nodal sampling or biopsy for study disease).
  • •2\. Patients with T1\-2N1 or T1N2\-3\.
  • •3\. Pre\-existing peripheral neuropathy \= Grade 2 (motor or sensory).
  • •4\. Weight loss \> 20% of body weight within 3 months of screening (unless purposeful).
  • •5\. Surgery \= 28 days before randomization with the exception of feeding tube
  • •placement, dental extractions, central venous catheter placement, biopsies and
  • •nodal sampling.
  • •6\. Cancer of the nasopharynx, sinus, salivary gland or skin.
  • •7\. Previous radical RT to the head and neck region, excluding superficial RT for a nonmelanomatous skin cancer.

Outcomes

Primary Outcomes

Not specified

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