Phase III A Prospective, Randomized, Rater-blinded, Multicentre Interventional Clinical Trial. Do Selective Radiation Dose Escalation and Tumour Hypoxia Status Impact the Locoregional Tumour Control After Radiochemotherapy of Head & Neck Tumours?
The study is a multicenter phase III randomized trial on the effect of dose escalated
radiotherapy with concomitant chemotherapy to treat local advanced head and neck cancer. The
study compares two treatment arms:
Experimental intervention (group A): 7 weeks standard radio-chemotherapy with 20 mg/m²/d
Cisplatin in week 1 and 5 including simultaneous radiation dose escalation (5x2.3 Gy per
week up to 80.5 Gy total dose) to the primary tumour and involved neck nodes ≥ 2 cm.
The Dose Escalated tumour Volume (DEVPT) is defined by the macroscopic (Gross) primary
Tumour Volume (GTVPT) minus a 3 mm margin at organs at risk or at mucosal sites to reduce
the risk of high dose deposition at the surrounding normal tissue. All involved lymph nodes
visualized by CT with a minimal diameter of 2 cm are also included for dose escalation
(DEVLN). The DEVLN of the lymph nodes > 2 cm is determined by the involved lymph node volume
(GTVLN) minus a margin of 3 mm at organs at risk or mucosal sites. The 3 mm margin as well
as the part of the target volume with suspected microscopic tumor extension receives 2 Gy
Control intervention (group B): 7 weeks standard radio-chemotherapy with 5x2.0 Gy per week
up to a total dose of 70 Gy and 20 mg/m²/d Cisplatin in week 1 and 5.
In group A and B: The treatment of the elective cervical lymphatic areas is given in the
same session as the GTV but with a single dose of 1.6 Gy up to 56 Gy (so called simultaneous
integrated boost concept).
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
2 year-loco-regional control
Michael Molls, Prof. Dr.
Klinik für Strahlentherapie und Radiologische Onkologie, Klinikum rechts der Isar der TU München Ismaningerstr. 22; 81675 Munich, Germany
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte