Study flow chart
Study info sheet
Study design	Prospective randomized multicenter trial, recruitment of non-randomized patients ("comprehensive cohort study")
Study leadership	Prof. Dr. Dr. O. Schober (study chairman), Dr. M. Biermann (study coordinator) Department of Nuclear Medicine, Münster University. Prof. Dr. N. Willich (vice chairman), Dr. A. Schuck (study coordinator) Department of Radiotherapy, Münster University. Prof. Dr. H.W. Schmid, Institute of Pathology, University of Essen Prof. Dr. W. Böcker, Prof. Dr. Gabriele Köhler  Institute of  Pathology, Münster University. Prof. Dr. W. Köpcke, Dr. A. Heinecke Institute of  Medical Informatics, Münster University. Prof. Dr. med. N. Senninger Department of General Surgery, Münster University. Prof. Dr. med. H. Dralle Department of General Surgery, University of Halle-Wittenberg.
Ethics committee approval	Münster University, 16 June 1997
Indication	locally invasive differentiated thyroid carcinoma (DTC) in UICC stage pT4 pN0/1/x M0 R0-1
Objective	To define the clinical use of adjuvant percutaneous radiotherapy in the treatment of stage pT4 pN0/1/x M0 R0-1 DTC
Endpoints	primary endpoints: locoregional recurrence rates, rates of distant metastases, cancer-specific mortality, total mortality secondary endpoints: early and late toxicity due to radiotherapy according to RTOG/EORTC criteria, adverse events, quality of life (EORTC QLQ-C30 questionnaire)
Inclusion criteria	locally invasive papillary or follicular DTC without distant metastases (= TNM categories  pT3/4 pN0/1/x R0-1 M0/x [6th ed. 2002] / pT4 pN0/1/x R0-1 M0/x [5th ed. 1997]), age  ³ 18 and < 70 years at the time of initial surgery, completion of surgical therapy with R0/1 resection, Karnofsky index ³70%, exclusion of pregnancy, informed patient consent, no detection of distant metastases (M0) after completion of primary staging
Exclusion criteria	secondary carcinoma (except basalioma), pregnancy, serious medical disease precluding adherence to the study protocol, inability to give informed patient consent, recurrence of previous DTC
Requirements for Randomisation	confirmation of histological diagnosis on review of the slides/specimens by reference pathologist(s), no detection of distant metastases (stage M0) at re-staging 3 months after initial ablative radioiodine therapy of the thyroid remnant
Randomization	stratified according to histological type (papillary v. follicular), nodal status (pN0 v. pN1/x) and participating center: Arm A: percutaneous radiotherapy after completion of ablative radioiodine therapy Arm B: no percutaneous radiotherapy
Non-randomized patients	Allocation by the participation center: Arm A: percutaneous radiotherapy after completion of ablative radioiodine therapy Arm B: no percutaneous radiotherapy
Recruitment	500 randomized patients in 5 years
Follow-up	at least 3 years after end of recruitment period, after publication of results continued observation of survival status
Study begin	1 Oct 2000 (run-in phase since 1 Dec 1999)
Study completion	1 Oct 2008
Partcipating centers	47 centers in Germany, Austria and Switzerland
Back to Homepage	(c) Münster University, 2001, 2002