SWOG clinical trial number
SWOG-9451
Induction Chemotherapy Followed by Chemoradiation for Organ Preservation in Patients with Advanced Resectable Cancer of the Hypopharynx and Base of Tongue, Phase II
Closed
Phase
Accrual
87%
Published
Abbreviated Title
Resectable Head and Neck
Activated
04/12/1996
Closed
12/01/2001
Research committees
Head and Neck Cancer
Treatment
Cisplatin
5-Fluorouracil
Eligibility Criteria Expand/Collapse
Pts. must have newly diagnosed, previously untreated, histologically proven squamous cell carcinoma of the base of tongue or hypopharynx, selected Stage III (T2N1M0, T3N0M0, T3N1M0) or IV (T2N2M0, T3N2M0, T3N3MO) w/ no evidence of distant mets; pts. dz must be considered surgically resectable, for pts. w/hypopharyngeal ca, the surgery which would ordinarily be required for tx of tumor must be a total laryngectomy; pts. must have meas or eval dz; PS 0 or 1; pts. must be evaluated by otolaryngology, radiation oncology, medical oncology and hospital dentistry w/in 42 days prior to registration; baseline audiogram performed w/in 42 days prior to reg (avg. hearing loss in both ears must not exceed 40 dB in the 50-2000 Hz range); serum creat <= 2 x IULN and creat clear > or = 60 ml/min; WBC >= 3,000, granulocytes >= 1,500, platelets >= 100,000; serum bilirubin <= 2 x IULN and SGOT or SGPT <= 3 x IULN; serum magnesium w/in institutional limits of normal (ok to supplement magnesium to achieve normal value); chest x-ray w/in 42 days prior to reg.
Publication Information Expand/Collapse
2005
Organ preservation for advanced resectable cancer of the base of tongue and hypopharynx: a Southwest Oncology Group trial
2002
Induction chemotherapy followed by chemoradiation for organ preservation in patients (pts) with advanced resectable cancer of the base of tongue (BOT) and hypopharynx (HP): a Southwest Oncology Group trial.