Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2000-01-31
2010-01-31
Brief Summary
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Detailed Description
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The treatment protocol is in accordance with current guidelines in Germany and includes total thyroidectomy (TT) with central lymphadenectomy (LNA), RIT to ablate the thyroid remnant, and TSH-suppressive therapy with L-thyroxine (TSH \< 0.1 mU/l). RIT is administered under endogenous TSH-stimulation after 4 weeks' cessation of L-thyroxine using standard activities of 1-4, and 1-2, GBq I-131 in patients with a 24-h-I-131 uptake below 10 % and 10-20 %, resp., or individual dosimetry aiming for at least 300 Gy in the thyroid remnant. If scintigraphic I-131 uptake by the thyroid remnant persists at whole-body scintigraphy (at least 200 MBq; at least 48 h) 3 months after RIT, a second fraction of RIT is given with 4-10 GBq.
Patients who consented to randomization at centers actively taking part in randomization were randomized to treatment arms A (additional adjuvant RTx) and B (no RTx) 3 months after initial RIT after confirmation of the histological diagnosis by the reference pathologist and when distant metastases had been excluded by means of serum thyroglobulin (Tg), WBS (s. a.) and a native thoracic computed tomogram (CCT). Randomization was stratified according to histological type (papillary v. follicular), nodal status (pN0/1/x), and participating center, and performed by an operator-independent randomization routine embedded in the database. The remaining patients were assigned to arms A and B by the participating centers.
RTx is begun after documented elimination of cervical I-131 uptake in a I-131 WBS 3 months after the last fraction of ablative RIT. RT includes the thyroid bed (in unilateral tumors only the affected side) with a dose of 59.4 Gy and 66.6 Gy after R0 and R1 resection, resp., and the regional lymph nodes of the neck and upper mediastinum including the posterior cervical chain from the mandible and mastoid process to the tracheal bifurcation with a dose of 50.4 Gy and 54.0 Gy in pN0 and pN1/x disease, resp. Fractionation is conventional (1.8 Gy/d 5 days a week). 3-D planning according to IRCU 50 is mandatory.
Patient follow-up includes, as a minimum, out-patient appointments with cervical ultrasound and measurement of serum TSH, hTG, anti-Tg antibodies and a blood count 2 and 8 months after each RIT or WBS, and a WBS (with at least 200 MBq over at least 48 h) under endogenous TSH-stimulation 3 and 12 months after ablative RIT and then at 24-month intervals. FDG-PET and other imaging modalities can be performed if needed. At each follow-up appointment, RTx toxicity is recorded according to RTOG criteria and quality of life by the QLQ-C30 questionnaire (v. 3.0 German) of the EORTC.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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external beam radiotherapy
Eligibility Criteria
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Inclusion Criteria
* completion of primary surgical therapy with R0 (no tumor residues) or R1 (microscopic residues) resection
* Karnofsky index \> 70 %
* freedom from distant metastases at the time of initial radioiodine therapy
* informed patient consent
Exclusion Criteria
* pregnancy
* serious general disease
* serious psychiatric disorder
* inability to give informed consent
* previous RTx
* recurrence of previous thyroid cancer
18 Years
69 Years
ALL
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
University Hospital Muenster
OTHER
Principal Investigators
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Otmar Schober, Prof MD PhD
Role: STUDY_CHAIR
Department of Nuclear Medicine, Münster University Hospital, Münster, Germany
Henning Dralle, Prof MD
Role: STUDY_DIRECTOR
Dept. of General Surgery, University Halle-Wittenberg, Halle, Germany
Normann Willich, Prof MD
Role: STUDY_DIRECTOR
Department of Radiooncology, Münster University Hospital, Münster, Germany
Martin Biermann, MD
Role: STUDY_DIRECTOR
Dept. of Nuclear Medicine, Münster University Hospital
Burkhard Riemann, MD PhD
Role: STUDY_DIRECTOR
Dept. of Nuclear Medicine, Münster University Hospital
Andreas Schuck, MD PhD
Role: STUDY_DIRECTOR
Dept. of Radiooncology, Münster University Hospital
Locations
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Department of Nuclear Medicine
Linz, , Austria
Department of Nuclear Medicine, Wien University Hospital
Vienna, , Austria
Department of Nuclear Medicine, Cologne University
Cologne, , Germany
Department of Nuclear Medicine, University Halle-Wittenberg
Halle, , Germany
Department of Nuclear medicine, Saarland University
Homburg/Saar, , Germany
Department of Nuclear Medicine, Münster University Hospital
Münster, , Germany
Department of Nuclear Medicine, Katharinen-Hospital
Stuttgart, , Germany
Department of Nuclear Medicine, Helios-Klinikum Wuppertal
Wuppertal, , Germany
Department of Nuclear Medicine, Würzburg University
Würzburg, , Germany
Department of Nuclear Medicine, Zürich University Hospital
Zurich, , Switzerland
Countries
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References
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Puskas C, Schober O. [Adjuvant percutaneous radiation of locally advanced papillary and follicular thyroid carcinoma: reflections for the necessity of a prospective multicenter study]. Nuklearmedizin. 1999;38(8):328-32. German.
Biermann M, Schober O; Multizentrische Studie Differenziertes Schilddrusenkarzinom Studiengruppe. [How many high-risk patients with differentiated thyroid cancer need a "Tumor Center" per year?]. Nuklearmedizin. 2002 Apr;41(2):61-2. No abstract available. German.
Biermann M, Schober O. GCP-compliant management of the Multicentric Study Differentiated Thyroid Carcinoma (MSDS) with a relational database under Oracle 8i. Inform Biom Epidemiol Med Biol 33:441-59, 2002
Biermann M, Pixberg M, Schuck A, Willich N, Heinecke A, Schober O. External beam radiotherapy. An evidence-based review. In: Biersack H-J, Grünwald F, eds. Thyroid cancer. Heidelberg: Springer; 139-61, 2005.
Biermann M, Pixberg MK, Schuck A, Heinecke A, Kopcke W, Schmid KW, Dralle H, Willich N, Schober O. Multicenter study differentiated thyroid carcinoma (MSDS). Diminished acceptance of adjuvant external beam radiotherapy. Nuklearmedizin. 2003 Dec;42(6):244-50.
Schuck A, Biermann M, Pixberg MK, Muller SB, Heinecke A, Schober O, Willich N. Acute toxicity of adjuvant radiotherapy in locally advanced differentiated thyroid carcinoma. First results of the multicenter study differentiated thyroid carcinoma (MSDS). Strahlenther Onkol. 2003 Dec;179(12):832-9. doi: 10.1007/s00066-003-1158-1.
Biermann M, Pixberg MK, Dorr U, Dietlein M, Schlemmer H, Grimm J, Zajic T, Nestle U, Ladner S, Sepehr-Rezai S, Rosenbaum S, Puskas C, Fostitsch P, Heinecke A, Schuck A, Willich N, Schmid KW, Dralle H, Schober O; MSDS study group. Guidelines on radioiodine therapy for differentiated thyroid carcinoma: impact on clinical practice. Nuklearmedizin. 2005;44(6):229-34, 236-7.
Vrachimis A, Wenning C, Gerss J, Dralle H, Vaez Tabassi M, Schober O, Riemann B; MSDS study group. Not all DTC patients with N positive disease deserve the attribution "high risk". Contribution of the MSDS trial. J Surg Oncol. 2015 Jul;112(1):9-14. doi: 10.1002/jso.23948. Epub 2015 Jun 12.
Riemann B, Kramer JA, Schmid KW, Dralle H, Dietlein M, Schicha H, Sauerland C, Frankewitsch T, Schober O; MSDS study group. Risk stratification of patients with locally aggressive differentiated thyroid cancer. Results of the MSDS trial. Nuklearmedizin. 2010;49(3):79-84. doi: 10.3413/nukmed-0302.
Biermann M, Pixberg M, Riemann B, Schuck A, Heinecke A, Schmid KW, Willich N, Dralle H, Schober O; MSDS study group. Clinical outcomes of adjuvant external-beam radiotherapy for differentiated thyroid cancer - results after 874 patient-years of follow-up in the MSDS-trial. Nuklearmedizin. 2009;48(3):89-98; quiz N15. doi: 10.3413/nukmed-0221. Epub 2009 Mar 23.
Other Identifiers
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Deutsche Krebshilfe 70-2294
Identifier Type: -
Identifier Source: secondary_id
MSDS
Identifier Type: -
Identifier Source: org_study_id