Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Christopher Wilke
Study ID
NCT02128906
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Cisplatin 40 mg/m2 weekly x 7
  • IMRT — RADIATION
    IMRT: once daily, M-F, 7 weeks (70 Gy)
  • Docetaxel — DRUG
    Docetaxel 15 mg/m2 weekly x 7
  • Cetuximab — DRUG
    Cetuximab 400 mg/m2 load, one week prior to IMRT Cetuximab 250 mg/m2 weekly x 7

Study Details

The goal of this clinical research study is to learn which chemotherapy combination may be more effective in treating locally advanced head and neck squamous cell carcinoma (HNSCC). The side effects of these combinations will also be studied. This study treatment consists of intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. For study chemotherapy, patients will be randomized between cisplatin or the combination of docetaxel and cetuximab. Subjects will be stratified depending on HPV status and the presence of ERCC-1 \[4F9\] in the tumor prior to randomization. The study will evaluate cisplatin vs. docetaxel-cetuximab in the overall population, and test which radiation and chemotherapy combination works best in relationship to how much ERCC-1 \[4F9\] is expressed in a tumor.

Key Dates

Start date
Dec 23, 2013
Status verified
Apr 2026
Primary completion
Dec 16, 2031
Completion
Dec 16, 2031

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cisplatin-IMRT
    Cisplatin 40 mg/m2 weekly x 7; IMRT: once daily, M-F, 7 weeks (70 Gy)
  • Active Comparator: Docetaxel-Cetuximab-IMRT
    Docetaxel 15 mg/m2 weekly x 7; Cetuximab 400 mg/m2 load, one week prior to IMRT; Cetuximab 250 mg/m2 weekly x 7; IMRT: once daily, M-F, 7 weeks (70 Gy)

Primary Outcome Measure

Time To Progression (TTP) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer Center - Radiation OncologyPittsburghPennsylvania15232
Samantha Demko, RN
[email protected]
412-647-9015
Brieana Marino, MS
[email protected]
412-647-8258
Christopher T Wilke, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
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By specialty
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By research site
UPMC Hillman Cancer Center - Radiation Oncology· Pittsburgh, PA

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