Thyroid NeoplasmsPhase 3NCT00144079
Multicenter Study Differentiated Thyroid Carcinoma
A Phase 3 study testing external beam radiotherapy in people with Thyroid Neoplasms, run by University Hospital Muenster at 10 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- external beam radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jan 2000to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- secondary malignancy except basalioma
- pregnancy
- serious general disease
- serious psychiatric disorder
- inability to give informed consent
- previous RTx
- recurrence of previous thyroid cancer
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Germany7 sites
Department of Nuclear Medicine, Cologne University
Cologne, 50924
Department of Nuclear Medicine, University Halle-Wittenberg
Halle, 06097
Department of Nuclear medicine, Saarland University
Homburg/Saar, 66421
Department of Nuclear Medicine, Münster University Hospital
Münster, 48129
Department of Nuclear Medicine, Katharinen-Hospital
Stuttgart, 70174
Department of Nuclear Medicine, Helios-Klinikum Wuppertal
Wuppertal, 44283
Department of Nuclear Medicine, Würzburg University
Würzburg, 97080
Austria2 sites
Department of Nuclear Medicine
Linz, 4010
Department of Nuclear Medicine, Wien University Hospital
Vienna, 1090
Switzerland1 site
Department of Nuclear Medicine, Zürich University Hospital
Zurich, 8091
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Neoplasms
- Being tested
- external beam radiotherapy
- Keywords
- Differentiated thyroid carcinoma, radiotherapy, radioiodine therapy, thyroidectomy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external beam radiotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJan 2000
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Investigators
- Otmar Schober, Prof MD PhD, Study chair, Department of Nuclear Medicine, Münster University Hospital, Münster, GermanyHenning Dralle, Prof MD, Study director, Dept. of General Surgery, University Halle-Wittenberg, Halle, GermanyNormann Willich, Prof MD, Study director, Department of Radiooncology, Münster University Hospital, Münster, GermanyMartin Biermann, MD, Study director, Dept. of Nuclear Medicine, Münster University HospitalBurkhard Riemann, MD PhD, Study director, Dept. of Nuclear Medicine, Münster University HospitalAndreas Schuck, MD PhD, Study director, Dept. of Radiooncology, Münster University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144079
- Sponsor's protocol ID
- MSDS
- Other IDs
- Deutsche Krebshilfe 70-2294
- Status last verified
- Sep 2005
- First submitted
- 1 Sep 2005
- Last updated
- 9 May 2006
- Results posted
- No
Publications
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.
PubMed 10615667Biermann 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.
PubMed 11989299Biermann 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.
PubMed 14668957Schuck 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.
PubMed 14652672Biermann 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.
PubMed 16400382Vrachimis 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.
PubMed 26074402Riemann 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.
PubMed 20505894Biermann 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.
PubMed 19322503
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Trial of Adjuvant External Beam Radiotherapy for Locally Invasive Differentiated Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT00144079
- Acronym / sponsor ID
- MSDS
- Conditions
- Thyroid Neoplasms
- Keywords
- Differentiated thyroid carcinoma, radiotherapy, radioiodine therapy, thyroidectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- Jan 2000
- Study completion
- Jan 2010
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- secondary malignancy except basalioma
- pregnancy
- serious general disease
- serious psychiatric disorder
- inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external beam radiotherapy | Procedure or surgery | – |
Primary outcome
time to local or distant failure
cancer-related mortality
3 secondary outcomes
acute toxicity of radiotherapy (RTOG)
chronic toxicity of radiotherapy (RTOG)
quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2006.
- Background: PubMed 10615667Puskas 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.
- Background: PubMed 11989299Biermann 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.
- BackgroundBiermann 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
- BackgroundBiermann 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.
- Results publication: PubMed 14668957Biermann 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.
- Results publication: PubMed 14652672Schuck 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.
- Results publication: PubMed 16400382Biermann 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.
- Derived from this study: PubMed 26074402Vrachimis 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.
- Derived from this study: PubMed 20505894Riemann 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.
- Derived from this study: PubMed 19322503Biermann 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.
Related trials for Thyroid Neoplasms
RecruitingPhase 2
The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
Metastic Thyroid Cancer
RecruitingObservational study
Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
Papillary Thyroid Cancer
RecruitingPhase 3
Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer
Nasolacrimal Duct Obstruction, Thyroid Cancer
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Recruiting
Thyroid Artery Embolization for the Treatment of Compressive Goiters.
Thyroid Nodules
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Otmar Schober, Prof MD PhD study chair
Department of Nuclear Medicine, Münster University Hospital, Münster, Germany
Henning Dralle, Prof MD study director
Dept. of General Surgery, University Halle-Wittenberg, Halle, Germany
Normann Willich, Prof MD study director
Department of Radiooncology, Münster University Hospital, Münster, Germany
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing external beam radiotherapy in people with Thyroid Neoplasms, run by University Hospital Muenster at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to local or distant failure. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144079, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2006.