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Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state) - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

Maximilian Moergel1, Antje Jahn-Eimermacher2, Frank Krummenauer3, Torsten E Reichert4, Wilfried Wagner1, Thomas G Wendt5, Jochen A Werner6 and Bilal Al-Nawas1*

Author Affiliations

1 Department of Oral and Maxillofacial Surgery, University of Mainz, Medical Center, Augustusplatz 2, D-55131 Mainz, Germany

2 Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University of Mainz, Medical Center, Obere Zahlbacherstr. 69, D-55131 Mainz, Germany

3 Department of Medical Biostatistics and Epidemiology, University of Witten-Herdecke, Alfred-Herrenhaus Str. 50, D-58448 Witten-Herdecke, Germany

4 Department of Oral and Maxillofacial Surgery, University of Regensburg, Medical Center, Franz Josef Strauß Allee 11, D-93053 Regensburg, Germany

5 Department of Radiation Oncology, University of Jena, University Hospital, Bachstr. 18, D-07743 Jena, Germany

6 Department of Otolaryngology, University of Marburg, Medical Center, Deutschstraße 3, D-35037 Marburg, Germany

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Trials 2009, 10:118  doi:10.1186/1745-6215-10-118

Published: 23 December 2009

Abstract

Background

Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation.

Methods/Design

The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome.

Conclusion

The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study.

Trial registration

ClinicalTrials.gov: NCT00964977