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SBRT With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated SCCHN

NCT02057107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-05

No results posted yet for this study

Summary

The aim of this trial is to examine the addition of docetaxel on disease progression, metastasis and survival of patients otherwise treated with SBRT and cetuximab alone. To better resolve the impact of the experimental treatment the presence/absence of prior cetuximab treatment will be determine before assigning treatment to either cetuximab and SBRT only or cetuximab, SBRT, and docetaxel.

Conditions

  • Previously-Irradiated
  • Squamous Cell Carcinoma of the Head and Neck Cancer

Interventions

RADIATION

SBRT

8.8-10 Gy per fraction (total: 44-50 Gy)

DRUG

Cetuximab

Day -7 (One week prior to commencement of stereotactic radiosurgery): Cetuximab, 400 mg/m2 Days 0 and 8 (The 1st and 2nd week of radiosurgery): Cetuximab, 250 mg/m2 Cetuximab, 250 mg/m2 will be given weekly ( following radiosurgery)

DRUG

Docetaxel

Days 0 and 8 (The 1st and 2nd week of radiosurgery) Docetaxel, 25 mg/m2 Docetaxel, 25 mg/m2 will be given weekly (following radiosurgery)

Sponsors & Collaborators

  • Heath Skinner

    lead OTHER

Principal Investigators

  • David A Clump, MD · UPMC Hillman Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-03
Primary Completion
2019-03-15
Completion
2019-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02057107 on ClinicalTrials.gov