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


CONCLUSIONS
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.


BACKGROUND
ISRCTN87356938.
Department of Radiation Oncology, University of Heidelberg, INF 400, 69120 Heidelberg, Germany.
Gregor
G
Habl
Alexandra D
AD
Jensen
Karin
K
Potthoff
Matthias
M
Uhl
Holger
H
Hof
Jacek
J
Hajda
Christian
C
Simon
Jürgen
J
Debus
Robert
R
Krempien
Marc W
MW
Münter
D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D000068818:Cetuximab; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005472:Fluorouracil / Q000008:administration & dosage; D005858:Germany; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000628:therapy; D053208:Kaplan-Meier Estimate; D007822:Laryngeal Neoplasms / Q000628:therapy; D009959:Oropharyngeal Neoplasms / Q000628:therapy; D010039:Otorhinolaryngologic Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D016190:Carboplatin; D000068818:Cetuximab; D005472:Fluorouracil