Detail

Study ID: Washington University APA Trial HNSCC 20151003

Title:

Two Arm Non-Randomized Phase II Trial of Induction Abraxane + Cisplatin followed by CisRT (Arm 1: AP+CRT) or Induction Abraxane Monotherapy followed by CetuxRT (Arm 2: A+ERT) for newly diagnosed pts with Stage III/IV HNSCC

Description:
Title: Phase II Non-Randomized Three Arm Trial of Induction Chemotherapy with nab-Paclitaxel and Cisplatin (AP: Arms 1 and 3) or Single Agent nab-Paclitaxel (A: Arm 2) as Induction Therapy followed by Definitive Concurrent Chemoradiation for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC): The APA Trial Description: The purpose of this research study is to look at the effectiveness and side effects associated with three different induction therapy regimens. Induction therapy is a treatment you receive before you undergo combined chemotherapy and radiation therapy. Induction therapy is given because research has shown that it will improve your chances of responding to treatment, and that the response you have to the induction therapy can help us predict how you will respond to the rest of your treatment. In this study, you will be placed in one of three treatment groups depending on your health status before you start treatment. Treatment after the completion of induction therapy will include chemotherapy and radiation therapy given at the same time.  People enrolling to Arm 1 will receive induction therapy with two drugs (nab-paclitaxel and cisplatin). People in Arm 1 will receive cisplatin with their radiation therapy. People in Arm 1 will receive 3 doses of cisplatin. People in Arm 1 who cannot receive further cisplatin for some reason will instead receive cetuximab with their radiation therapy.  People enrolling to Arm 2 will receive induction therapy with one drug (nab-paclitaxel only). People in Arm 2 will receive cetuximab with their radiation therapy.  People enrolling to Arm 3 will receive induction therapy with two drugs (nab-paclitaxel and cisplatin) followed by lower dose radiation therapy. Arm 3 will only include patients with HPV (human papilloma virus) related oropharyngeal squamous cell carcinoma (OPSCC). People in Arm 3 will receive cisplatin with their radiation therapy and they will only receive one dose of cisplatin. People in Arm 3 who cannot receive further cisplatin for some reason will instead receive cetuximab with their radiation therapy.
Location:
Sioux Falls Region
Principal Investigator:
Steven Powell, MD
Disease:
Head and Neck
Stage:
Phase II
Status:
Active - Open to Accrual