SWOG clinical trial number
S0217
Adjuvant Chemo-Radiotherapy with Combination of Cisplatin (NSC-119875)and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Closed
Phase
Accrual
13%
Abbreviated Title
Adjuvant, locally advanced squamous cell carcinoma
Activated
07/01/2005
Closed
01/10/2007
Participants
Research committees
Head and Neck Cancer
Treatment
Cisplatin
Docetaxel
Radiation Therapy
Eligibility Criteria Expand/Collapse
Pts must have selected Stage III or Stage IV SCCHN (w/ no distant mets). Pts w/ the following TNM are not eligible: T3-NO-M0, T4a-N0-M0, T4b-N3-M0. Pts w/ Stage IVC dz and pts w/ primary nasopharyngeal ca are not eligible. Pts must have had complete resection and one or more of the following risk factors: a) Multiple path. proven lymph node mets; b) One or more lymph nodes w/ extracapsular extension of tumor; c) Microscopically positive margin(s) of resection including mucosal margins and/or soft tissue of deep margins of resection. All srg to resect primary & nodal dz must have been completed w/i 56 days prior to reg w/ all srg complications, wound healing & toxcities resolved. Pts must have CT or CXR to rule out distant mets w/i 84 days prior to reg but no more than 28 days prior to definitive srg to resect all H&N dz. PS <=1. Must not have had prior RT or chemo for malignancy. Pts must have adequate hematologic, renal, and hepatic function (as defined in the protocol) w/i 28 days prior to reg. Pts w/ known h/o severe hypersensitivity reaction to products containing polysorbate 80 (Tween 80) are not eligible. Must not have evidence of pre-existing peripheral neuropathy. Must not be pregnant or nursing. Pts w/ reproductive potential must agree to use effective contraceptive method.