Docetaxel, cisplatin (TP), and radiation with or without cetuximab in advanced larynx carcinoma (DeLOS II trial).
Authors: A. Dietz, M. Flentje, R. Hagen, R. D. Kortmann, G. Hildebrand, F. Hoppe, I. Schwienhorst, U. Keilholz
Journal: Journal of Clinical Oncology (2010)

TPS265^ Background: The DeLOS II trial is a German multicenter (25 centers) randomized phase II trial investigating a docetaxel/cisplatin/5-fluorouracil (TPF) induction chemotherapy with or without cetuximab for patients with only by laryngectomy operable carcinoma of the larynx/hypopharynx, followed by radiotherapy. The goal is to preserve a functional larynx. Methods: Arm A: standard TPF (TP since Sept 2009). Radiation start in week 11; Arm B: Same treatment as arm A with the addition of cetuximab day 1 400 mg/m2 i.v. followed by weekly 250 mg/m2 i.v. for 16 weeks. Patients with no response after 4 weeks (first cycle) receive laryngectomy. Planned accrual is 85 patients per treatment arm (170 total). Primary Outcome Measures: Confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2 years after randomization. Total enrollment in January 2010 was 78 patients. Due to five toxic deaths among the first 62 patients (4 in arm A and 1 in arm B), 5FU was omitted from the induction chemotherapy, and accrual continues with TP with or without cetuximab + radiation due to 5 TPF-related toxic deaths in 60 patients. TPF with or without cetuximab is an effective, albeit toxic induction chemotherapy regimen for patients with SCC of the larynx. SCC of the larynx is often associated with a history of excessive smoking and the expected comorbidities, which may explain the degree of toxicity, which is unacceptable for operable carcinoma patients. TP with or without cetuximab may be an alternative for patients, to whom induction-chemotherapy followed by radiation is indicated for larynx preservation. No significant financial relationships to disclose. In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519-521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2010 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest. No significant financial relationships to disclose.