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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Time To Progression is the duration of time from date of study entry until the first appearance of new metastatic lesions or objective tumor progression in patients with increased tumoral ERCC1 expression. Progression is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstra

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
Christopher Wilke

2 total trials

What NCT02128906 shows while recruiting

NCT02128906 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 102-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (18% higher).

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 a single indexed study location in 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.

Similar trials for Squamous Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02128906's enrollment target sits among peer trials

120 11th of 47 higher than 37 of 47 other Squamous Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02128906, the US trial registry maintained by the National Library of Medicine. NCT02128906 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.