NCT00144079

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_3

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

May 9, 2006

Status Verified

September 1, 2005

First QC Date

September 1, 2005

Last Update Submit

May 8, 2006

Conditions

Thyroid Neoplasms

Keywords

Differentiated thyroid carcinomaradiotherapyradioiodine therapythyroidectomy

Outcome Measures

Primary Outcomes (2)

  • time to local or distant failure

  • cancer-related mortality

Secondary Outcomes (3)

  • acute toxicity of radiotherapy (RTOG)

  • chronic toxicity of radiotherapy (RTOG)

  • quality of life

Interventions

external beam radiotherapyPROCEDURE

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Department of Nuclear Medicine

Linz, 4010, Austria

Location

Department of Nuclear Medicine, Wien University Hospital

Vienna, 1090, Austria

Location

Department of Nuclear Medicine, Cologne University

Cologne, 50924, Germany

Location

Department of Nuclear Medicine, University Halle-Wittenberg

Halle, 06097, Germany

Location

Department of Nuclear medicine, Saarland University

Homburg/Saar, 66421, Germany

Location

Department of Nuclear Medicine, Münster University Hospital

Münster, 48129, Germany

Location

Department of Nuclear Medicine, Katharinen-Hospital

Stuttgart, 70174, Germany

Location

Department of Nuclear Medicine, Helios-Klinikum Wuppertal

Wuppertal, 44283, Germany

Location

Department of Nuclear Medicine, Würzburg University

Würzburg, 97080, Germany

Location

Department of Nuclear Medicine, Zürich University Hospital

Zurich, 8091, Switzerland

Location

Related Publications (10)

  • 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.

    PMID: 10615667BACKGROUND

  • 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.

    PMID: 11989299BACKGROUND

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 14668957RESULT

  • 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.

    PMID: 14652672RESULT

  • 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.

    PMID: 16400382RESULT

  • 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.

    PMID: 26074402DERIVED

  • 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.

    PMID: 20505894DERIVED

  • 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.

    PMID: 19322503DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Otmar Schober, Prof MD PhD

    Department of Nuclear Medicine, Münster University Hospital, Münster, Germany

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

January 1, 2000

Study Completion

January 1, 2010

Last Updated

May 9, 2006

Record last verified: 2005-09

Locations

CH(1)DE(7)AU(2)