{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"12"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"description":"The primary clinical objective of this trial is to compare the larynx preservation rates in a treatment paradigm that uses induction chemotherapy plus AT-101 to select patients for either concurrent chemoradiation or surgery. Organ preservation rate, defined as alive and free from indication for laryngectomy three months post treatment, was chosen as the primary endpoint because it provides evidence to fully characterize clinically the effect of the treatment strategy","groups":[{"description":"platinum/docetaxel + AT-101 The platinum will either be cisplatin or carboplatin as deemed best by the medical oncologist.\n\n(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).\n\n(AT-101 Arm) Days #1-3: Patients will receive AT-101 40 mg orally twice daily On Day 23 (+/- 3 days), there will be a direct laryngoscopy (DL) with tumor biopsy and blood draw, repeat CT scan of the neck with perfusion within a week biopsy.\n\nAT-101: Patients will receive AT-101 40 mg orally two times a day.\n\nCisplatin: Cisplatin 100 mg/m2\n\nCarboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg","id":"OG000","title":"Platinum/Docetaxal + AT-101"},{"description":"(Both Arms) Day #1: Patients will undergo induction chemotherapy with (TP) docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 (or Carboplatin AUC 6).\n\nDay #23 (+/- 3 days): Patients will undergo a direct laryngoscopy (DL) with biopsy. Patients will also undergo a repeat CT scan of the neck with perfusion within a week (+/-) of their perspective biopsies.\n\nDocetaxel: Docetaxel (Taxotere) 75 mg/m2\n\nCisplatin: Cisplatin 100 mg/m2\n\nCarboplatin: Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg","id":"OG001","title":"Active Comparator Arm"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Up to 3 months after end of treatment","title":"Number of Patients Alive and Free From Indication for Laryngectomy Three Months Post Treatment","type":"PRIMARY","unitOfMeasure":"Participants"}