Treatment of locally advanced carcinomas of head and neck with intensity-modulated radiation therapy (IMRT) in combination with cetuximab and chemotherapy: the REACH protocol.

Abstract

BACKGROUND:

Primary treatment of carcinoma of the oro-/hypopharynx or larynx may consist of combined platinum-containing chemoradiotherapy. In order to improve clinical outcome (i.e. local control/overall survival), combined therapy is intensified by the addition of the EGFR inhibitor cetuximab (Erbitux®). Radiation therapy (RT) is carried out as intensity-modulated RT (IMRT) to avoid higher grade acute and late toxicity by sparing of surrounding normal tissues.

METHODS/DESIGN:

The REACH study is a prospective phase II study combining chemoradiotherapy with carboplatin/5-Fluorouracil (5-FU) and the monoclonal epidermal growth factor-receptor (EGFR) antibody cetuximab (Erbitux®) as intensity-modulated radiation therapy in patients with locally advanced squamous-cell carcinomas of oropharynx, hypopharynx or larynx.Patients receive weekly chemotherapy infusions in the 1st and 5th week of RT. Additionally, cetuximab is administered weekly throughout the treatment course. IMRT is delivered as in a classical concomitant boost concept (bid from fraction 16) to a total dose of 69,9 Gy.

DISCUSSION:

Primary endpoint of the trial is local-regional control (LRC). Disease-free survival, progression-free survival, overall survival, toxicity, proteomic and genomic analyses are secondary endpoints. The aim is to explore the efficacy as well as the safety and feasibility of this combined radioimmunchemotherapy in order to improve the outcome of patients with advanced head and neck cancer.

TRIAL REGISTRATION:

ISRCTN87356938.

• Authors: Gregor Habl, Alexandra D Jensen, Karin Potthoff, Matthias Uhl, Holger Hof, Jacek Hajda, Christian Simon, Jürgen Debus, Robert Krempien, Marc W Münter
• Journal: BMC cancer (BMC Cancer) Vol. 10 Pg. 651 (Nov 26 2010) ISSN: 1471-2407 [Electronic] England
• PMID: 21108850 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Carboplatin
• Cetuximab
• Fluorouracil

Topics

• Antibodies, Monoclonal (administration & dosage)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carboplatin (administration & dosage)
• Carcinoma, Squamous Cell (drug therapy, mortality, pathology, surgery, therapy)
• Cetuximab
• Chemotherapy, Adjuvant
• Disease-Free Survival
• Fluorouracil (administration & dosage)
• Germany
• Humans
• Hypopharyngeal Neoplasms (therapy)
• Kaplan-Meier Estimate
• Laryngeal Neoplasms (therapy)
• Oropharyngeal Neoplasms (therapy)
• Otorhinolaryngologic Neoplasms (drug therapy, mortality, pathology, radiotherapy, therapy)
• Prospective Studies
• Radiotherapy, Adjuvant
• Radiotherapy, Intensity-Modulated (adverse effects)
• Time Factors
• Treatment Outcome