Multicenter Study Differentiated Thyroid Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144079
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : May 9, 2006
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by:
University Hospital Muenster

Brief Summary:
The trial examines the clinical benefit of adjuvant external beam radiotherapy (RTx) for locally invasive differentiated carcinoma (TNM stages pT4 pN0/1/x M0/x; 5th ed. 1997) of the thyroid gland (DTC). Patients are treated with surgery (thyroidectomy and lymphadenectomy), radioiodine therapy (RIT) to ablate the thyroid remnant tissue, and TSH-suppressive L-thyroxine therapy with or without RTx after documented elimination of cervical I-131 uptake.

Condition or disease Intervention/treatment Phase
Thyroid Neoplasms Procedure: external beam radiotherapy Phase 3

Detailed Description:

MSDS was designed as a comprehensive cohort trial with randomization and observation arms. Patients are enrolled at the time of the first ablative radioiodine therapy (RIT). Inclusion criteria are papillary or follicular DTC pT4 pN0/1/x M0/x, age between 18 (incl.) and 70 years (excl.) at the time of initial surgery, completion of primary surgical therapy with R0 (no tumor residues) or R1 (microscopic residues) resection, Karnofsky index of at least 70 %, freedom from distant metastases at the time of initial radioiodine therapy (RIT), and informed patient consent. Criteria for exclusion are secondary malignancy except basalioma, pregnancy, serious general disease, serious psychiatric disorder, inability to give informed consent, previous RTx and recurrence of previous DTC. From 2003, the first inclusion criterion was changed into DTC pT3/4 pN0/1/x M0/x to reflect the 2002 revision of the TNM staging system.

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Trial of Adjuvant External Beam Radiotherapy for Locally Invasive Differentiated Thyroid Carcinoma
Study Start Date : January 2000
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Primary Outcome Measures :
  1. time to local or distant failure
  2. cancer-related mortality

Secondary Outcome Measures :
  1. acute toxicity of radiotherapy (RTOG)
  2. chronic toxicity of radiotherapy (RTOG)
  3. quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • papillary or follicular thyroid carcinoma pT4 pN0/1/x M0/x
  • 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:

  • secondary malignancy except basalioma
  • pregnancy
  • serious general disease
  • serious psychiatric disorder
  • inability to give informed consent
  • previous RTx
  • recurrence of previous thyroid cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144079

Department of Nuclear Medicine
Linz, Austria, 4010
Department of Nuclear Medicine, Wien University Hospital
Wien, Austria, 1090
Department of Nuclear Medicine, University Halle-Wittenberg
Halle, Germany, 06097
Department of Nuclear medicine, Saarland University
Homburg/Saar, Germany, 66421
Department of Nuclear Medicine, Cologne University
Köln, Germany, 50924
Department of Nuclear Medicine, Münster University Hospital
Münster, Germany, 48129
Department of Nuclear Medicine, Katharinen-Hospital
Stuttgart, Germany, 70174
Department of Nuclear Medicine, Helios-Klinikum Wuppertal
Wuppertal, Germany, 44283
Department of Nuclear Medicine, Würzburg University
Würzburg, Germany, 97080
Department of Nuclear Medicine, Zürich University Hospital
Zürich, Switzerland, 8091
Sponsors and Collaborators
University Hospital Muenster
Deutsche Krebshilfe e.V., Bonn (Germany)
Study Chair: Otmar Schober, Prof MD PhD Department of Nuclear Medicine, Münster University Hospital, Münster, Germany
Study Director: Henning Dralle, Prof MD Dept. of General Surgery, University Halle-Wittenberg, Halle, Germany
Study Director: Normann Willich, Prof MD Department of Radiooncology, Münster University Hospital, Münster, Germany
Study Director: Martin Biermann, MD Dept. of Nuclear Medicine, Münster University Hospital
Study Director: Burkhard Riemann, MD PhD Dept. of Nuclear Medicine, Münster University Hospital
Study Director: Andreas Schuck, MD PhD Dept. of Radiooncology, Münster University Hospital

Additional Information:
Publications of Results:
Other Publications:
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.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00144079     History of Changes
Other Study ID Numbers: MSDS
Deutsche Krebshilfe 70-2294
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: May 9, 2006
Last Verified: September 2005

Keywords provided by University Hospital Muenster:
Differentiated thyroid carcinoma
radioiodine therapy

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms