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NCT02128906 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Squamous Cell Carcinoma, sponsored by Christopher Wilke.

Recruiting
Registry status
Phase 2
Development phase
120
Enrollment target
1
Study location

NCT02128906 is a Phase 2 study of Squamous Cell Carcinoma that is actively recruiting participants, run by Christopher Wilke. The registered enrollment target is 120 participants, above the 102-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (18% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT02128906, a Phase 2 study of Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Christopher Wilke.

RECRUITING
Registry status
Phase 2
Development phase
120 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Docetaxel
  • DRUG Cisplatin
  • DRUG Cetuximab
  • RADIATION IMRT

Study Locations (1)

Pennsylvania

  • UPMC Hillman Cancer Center - Radiation Oncology - Pittsburgh

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2013-12-23
Est. Completion 2030-12
Phase Phase 2

Sponsor

Christopher Wilke

2 total trials

What the Registry Record Tells You About NCT02128906

The ClinicalTrials.gov registry entry for NCT02128906 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 102-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (18% higher). The listed sponsor is Christopher Wilke, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Squamous Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.

NCT02128906 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT02128906 about?

NCT02128906 is a clinical study titled "Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design". 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 rad...

What is the current status of trial NCT02128906?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2013-12-23. Estimated completion is 2030-12.

What conditions does trial NCT02128906 study?

This clinical trial studies the following conditions: Squamous Cell Carcinoma.

What interventions are being tested in trial NCT02128906?

The interventions under investigation include: Docetaxel (DRUG), Cisplatin (DRUG), Cetuximab (DRUG), IMRT (RADIATION).

Who is sponsoring clinical trial NCT02128906?

This trial is sponsored by Christopher Wilke, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02128906 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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