A Pilot Study to Evaluate Response to Neoadjuvant Chemotherapy With Cisplatin and Docetaxel Followed by Chemoradiation Therapy With Carboplatin in Stage IV Non-metastatic Head and Neck Cancer
Chemoradiotherapy has become the standard of care for patients with unresectable head and
neck cancer, but there can be substantial added toxicity with chemoradiotherapy compared to
radiation therapy alone. Neoadjuvant therapy with cisplatin / 5-fluorouracil has
demonstrated activity in this disease, and taxanes appear to improve response further.
Docetaxel / cisplatin / 5-fluorouracil has been shown to be a highly active regimen.
However, with the potential added toxicities of neoadjuvant chemotherapy, it is important to
minimize toxicity while maintaining efficacy. Chemotherapeutic agents that are DNA
cycle-specific like 5-fluorouracil are more stomatotoxic than those that are cell phase
non-specific. Of note, several studies have suggested that docetaxel and cisplatin is a
highly active combination when used for advanced disease or as neoadjuvant therapy .
This study will therefore test the efficacy of neoadjuvant chemotherapy with cisplatin and
docetaxel without 5-fluorouracil followed by chemoradiotherapy with carboplatin to determine
whether promising response rates with modest toxicity can be achieved. Carboplatin will be
used as the radiosensitizing agent during chemoradiotherapy to reduce nephrotoxicity and
neurotoxicity as compared to further treatment with cisplatin.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
6 months after initiation of therapy
Steven M Grunberg, MD
University of Vermont/Feltcher Allen Health Care
United States: Institutional Review Board
|Fletcher Allen Health Care||Burlington, Vermont 05401|
|Mountainview Medical Center||Berlin, Vermont 05602|
|Vermont Center for Cancer Medicine||Colchester, Vermont 05446|