SWOG clinical trial number
S0216

Docetaxel (NSC-628503), Cisplatin (NSC-119875), and 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed by Accerlerated Fractionation/Concomitant Boost Radiation and Concurrent Single Agent Cisplatin (NSC-119875), in Patients with Advanced Squamous Cell Head and Neck Cancer

Closed
Phase
Accrual
100%
Published
Abbreviated Title
SCCHN
Activated
03/01/2003
Closed
08/19/2004
Participants
NCORP, Members, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists

Research committees

Head and Neck Cancer

Treatment

Cisplatin 5-Fluorouracil Docetaxel Radiation Therapy

Eligibility Criteria Expand/Collapse

Pts must have previously untreated histologically proven dx of SCCHN (excluding lip, nasopharynx, paranasal sinus and salivary gland) based on bx or FNA of the primary lesion or neck mass. Pts must have Stage III or IV dz w/ no evidence of distant met. All pts must have neg CXR w/i 28 days prior to reg (note: Pts must have been determined to be appropriate for definitive RT w/ curative intent). Pts with unknown primary site are not elig. Dz must be documented by CT or MRI w/i 42 days prior to reg. Pts must not have myocardial infarction w/i the last 3 mo or not unstable or uncontrolled angina and not active systemic infection. PS 0 - 1. Pts must be evaluated by Radiation & Medical Oncologist w/i 28 day; pts must undergo evaluation by a H&N surgeon, to include, when appropriate, an exam under anesthesia w/ direct laryngoscopy, nasopharyngscopy, esophagoscopy, and bronchoscopy w/i 28 days prior to reg; and pts with teeth must be evaluated by dentistry w/i 28 days prior to reg. No prior therapeutic srg and pts must not have had RT or chemo of any kind for any reason. Pts must have adequate renal and hepatic function. Pts must have adequate hematologic values. Pregnant or nursing women may not elig.

Publication Information Expand/Collapse

2010

Docetaxel, cisplatin and fluorouracil induction chemotherapy followed by accelerated fractionation/concomitant boost radiation and concurrent cisplatin in patients with advanced squamous cell head and neck cancer: A Southwest Oncology Group phase II trial (S0216) [PMID: 19557750;PMC2967367]

DJ Adelstein;J Moon;E Hanna;PG Shankar Giri;GM Mills;GT Wolf;SG Urba Head and Neck, Feb; 32(2):221-228;

2007

S0216: a Southwest Oncology Group (SWOG) phase II trial of docetaxel (T), cisplatin (P), and fluorouracil (F) induction followed by accelerated fractionation/concomitant boost (AF/CB) radiotherapy (RT) and concurrent cisplatin for advanced head and neck squamous cell cancer (HNSCC)

DJ Adelstein;J Moon;E Hanna;SPG Giri;GM Mills;GT Wolf;SG Urba Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#6014