Multicenter Study Differentiated Thyroid Carcinoma

May 8, 2006 updated by: University Hospital Muenster

Phase 3 Trial of Adjuvant External Beam Radiotherapy for Locally Invasive Differentiated Thyroid Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4010
        • Department of Nuclear Medicine
      • Wien, Austria, 1090
        • Department of Nuclear Medicine, Wien University Hospital
  • Germany
      • Halle, Germany, 06097
        • Department of Nuclear Medicine, University Halle-Wittenberg
      • Homburg/Saar, Germany, 66421
        • Department of Nuclear medicine, Saarland University
      • Köln, Germany, 50924
        • Department of Nuclear Medicine, Cologne University
      • Münster, Germany, 48129
        • Department of Nuclear Medicine, Münster University Hospital
      • Stuttgart, Germany, 70174
        • Department of Nuclear Medicine, Katharinen-Hospital
      • Wuppertal, Germany, 44283
        • Department of Nuclear Medicine, Helios-Klinikum Wuppertal
      • Würzburg, Germany, 97080
        • Department of Nuclear Medicine, Würzburg University
  • Switzerland
      • Zürich, Switzerland, 8091
        • Department of Nuclear Medicine, Zürich University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
time to local or distant failure
cancer-related mortality

Secondary Outcome Measures

Outcome Measure
quality of life
acute toxicity of radiotherapy (RTOG)
chronic toxicity of radiotherapy (RTOG)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion

December 7, 2022

Study Completion

January 1, 2010

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2006

Last Update Submitted That Met QC Criteria

May 8, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSDS
  • Deutsche Krebshilfe 70-2294

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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