Synchronous Metastasized Breast CancerPOSYTIVENCT01015625

Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

A study testing Surgery and Surgery on Demand in people with Synchronous Metastasized Breast Cancer and Circulating Tumor Cells, run by Austrian Breast & Colorectal Cancer Study Group at 14 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Synchronous Metastasized Breast Cancer, Circulating Tumor Cells
What is being tested?: Surgery and Surgery on Demand
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 14 sitesAustria
Study dates: 24 Nov 2010to Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients age ≥ 18 years
Eastern Cooperative Oncology Group Performance Status is 0 -2
Untreated synchronous metastasized invasive carcinoma of the breast with the primary tumor in situ (bilateral synchronous metastasized breast cancer patients are eligible)
The primary tumor must be identified and may be any size, however, primary resection with resection free margins must be possible
Invasive adenocarcinoma of the breast on histological examination
The metastatic site must be identified by radiological assessment(Computer Tomography of the chest and the abdomen OR ultrasound and chest x ray for visceral metastases; bone scan AND/OR computer tomography AND/OR magnetic resonance for bone metastases). A biopsy is not necessary.
Written informed consent must be obtained and documented prior to beginning any protocol specific procedures and according to local regulatory requirements
able to comply with the protocol requirements during the treatment and follow-up period.

Who cannot join

Patients in whom a R0 resection (microscopic free margins) is clinically questionable
Inflammatory cancer
Patients with a brain metastasis
Patients who are not eligible for general anesthesia and operations
Patients without metastatic breast cancer (patients with a tumor marker value (CEA, CA15-3) above normal levels without the radiological proven evidence of metastases are not eligible for the study)
Patients with a second untreated malignancy

Show all 10Show fewer

Any previous malignancy treated with curative intent and the patient has not been disease-free for 5 years - exceptions are: (a)carcinoma in situ of the cervix, (b)squamous carcinoma of the skin, (c)basal cell carcinoma of the skin
Patients with any recurrent cancer disease
Pregnant or lactating women
Patients are not allowed to be part of another local therapy trial

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Austria14 sites

State Hospital Feldkirch
Feldkirch, Vorarlberg, 6807
Gynaegological Medical University Graz
Graz, Styria, 8036
Medical University Graz, Oncology
Graz, Styria, 8036
Hospital Guessing
Guessing, Burgenland, 7540
Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Ordensklinikum Linz GmbH - BHS Linz, Coop. Study Group
Linz, Upper Austria, 4010
Ordensklinikum Linz GmbH - Elisabethinen Linz
Linz, Upper Austria, 4010
General Hospital Linz
Linz, Upper Austria, 4020
Hospital Oberpullendorf
Oberpullendorf, Burgenland, 7350
Ordination Dr. Wette
Saint Veit A. D. Glan, Carinthia, 9300
Paracelsus Medical University Salzburg-Oncology, Coop. Group
Salzburg, 5020
Medical University of Vienna-General Hospital Vienna
Vienna, 1090
Medical University of Vienna
Vienna, 1090
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, 4600

Other trials in Austria

About this study

Official title: Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer, a Multicenter Prospective Randomized Study to Evaluate the Use of Local Therapy

Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy

Read the detailed description

This study is a prospective, randomized, multicentre, study concerning the influence of local treatment on the patients with synchronous metastasized breast cancer. Patients will be stratified at inclusion according to the centre, the menopausal status (pre-menopausal, post-menopausal), the hormone-receptor status (ER-/PR-/not determinable; any PR and/or Er+), the HER-2 status (positive vs. negative/not determinable), the grading (G1/G2/not determinable vs. G3), location of metastases (visceral ± vs bone only), organs with metastases (single organ vs multiple organs) and use of first line chemotherapy (anthracycline ± vs. taxane vs others). Thereafter patients will be randomly assigned to receive either local therapy of the breast (lumpectomy or mastectomy + axillary surgery /± radiotherapy) versus no local therapy. Systemic therapy will be administered at the centers policy.

Conditions: Synchronous Metastasized Breast Cancer, Circulating Tumor Cells
Being tested: Surgery, Surgery on Demand
Keywords: breast cancer, ABCSG, POSYTIVE, growth factor, median survival, surgery on demand, surgical therapy, blood specimen, tissue specimen, VEGF, TGF, circulating tumor cells, stem cells
Medical subject headings: Neoplastic Cells, Circulating, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SurgeryProcedure or surgery
lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
Surgery on DemandProcedure or surgery
if necessary local therapy on demand

Study groups in NCT01015625
Study group	Role	What they receive
A: Surgical Therapy	Other	Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory). Receives: Procedure: Surgery
B: Surgery on Demand	Other	In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat. Receives: Procedure: Surgery on Demand

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival (OS)
Overall Survival with vs without local therapy (surgery)
Measured: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months

Secondary outcomes (2)

Time to Distant Progression
Time to distant progression with vs without local therapy (surgery)
Measured: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
Time to Local Progression (TTPl)
Time to local progression with vs without local therapy (surgery)
Measured: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 2010Jul 2022

First posted18 Nov 2009 (estimated)
Study start24 Nov 2010
Primary completionJul 2022
Study completionJul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (31)Papers the sponsor has linked to this study.
Other trials for Synchronous Metastasized Breast CancerStudies 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01015625
Sponsor's protocol ID: ABCSG 28 / POSYTIVE
Other IDs: ABCSG 28
Acronym: POSYTIVE
Status last verified: Mar 2024
First submitted: 17 Nov 2009
Last updated: 19 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Babiera GV, Rao R, Feng L, Meric-Bernstam F, Kuerer HM, Singletary SE, Hunt KK, Ross MI, Gwyn KM, Feig BW, Ames FC, Hortobagyi GN. Effect of primary tumor extirpation in breast cancer patients who present with stage IV disease and an intact primary tumor. Ann Surg Oncol. 2006 Jun;13(6):776-82. doi: 10.1245/ASO.2006.03.033. Epub 2006 Apr 17.
PubMed 16614878
Blanchard DK, Bhatia P, Hilsenbeck SG, Elledge RM. Does surgical management of stage IV breast cancer effect outcome? SABCC 2006, San Antonio
Carmichael AR, Anderson ED, Chetty U, Dixon JM. Does local surgery have a role in the management of stage IV breast cancer? Eur J Surg Oncol. 2003 Feb;29(1):17-9. doi: 10.1053/ejso.2002.1339.
PubMed 12559070
Khan SA, Stewart AK, Morrow M. Does aggressive local therapy improve survival in metastatic breast cancer? Surgery. 2002 Oct;132(4):620-6; discussion 626-7. doi: 10.1067/msy.2002.127544.
PubMed 12407345
Rapiti E, Verkooijen HM, Vlastos G, Fioretta G, Neyroud-Caspar I, Sappino AP, Chappuis PO, Bouchardy C. Complete excision of primary breast tumor improves survival of patients with metastatic breast cancer at diagnosis. J Clin Oncol. 2006 Jun 20;24(18):2743-9. doi: 10.1200/JCO.2005.04.2226. Epub 2006 May 15.
PubMed 16702580
Gnerlich J, Jeffe DB, Deshpande AD, Beers C, Zander C, Margenthaler JA. Surgical removal of the primary tumor increases overall survival in patients with metastatic breast cancer: analysis of the 1988-2003 SEER data. Ann Surg Oncol. 2007 Aug;14(8):2187-94. doi: 10.1245/s10434-007-9438-0. Epub 2007 May 24.
PubMed 17522944
Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
PubMed 12393820
Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989.
PubMed 12393819
Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.
PubMed 16360786
Flanigan RC, Salmon SE, Blumenstein BA, Bearman SI, Roy V, McGrath PC, Caton JR Jr, Munshi N, Crawford ED. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med. 2001 Dec 6;345(23):1655-9. doi: 10.1056/NEJMoa003013.
PubMed 11759643
Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. doi: 10.1016/s0140-6736(01)06103-7.
PubMed 11583750
Norton L, Massague J. Is cancer a disease of self-seeding? Nat Med. 2006 Aug;12(8):875-8. doi: 10.1038/nm0806-875. No abstract available.
PubMed 16892025
Al-Hajj M, Clarke MF. Self-renewal and solid tumor stem cells. Oncogene. 2004 Sep 20;23(43):7274-82. doi: 10.1038/sj.onc.1207947.
PubMed 15378087
Bao S, Wu Q, McLendon RE, Hao Y, Shi Q, Hjelmeland AB, Dewhirst MW, Bigner DD, Rich JN. Glioma stem cells promote radioresistance by preferential activation of the DNA damage response. Nature. 2006 Dec 7;444(7120):756-60. doi: 10.1038/nature05236. Epub 2006 Oct 18.
PubMed 17051156
Al-Hajj M, Wicha MS, Benito-Hernandez A, Morrison SJ, Clarke MF. Prospective identification of tumorigenic breast cancer cells. Proc Natl Acad Sci U S A. 2003 Apr 1;100(7):3983-8. doi: 10.1073/pnas.0530291100. Epub 2003 Mar 10.
PubMed 12629218

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer, a Multicenter Prospective Randomized Study to Evaluate the Use of Local Therapy
ClinicalTrials.gov ID: NCT01015625
Acronym / sponsor ID: POSYTIVE / ABCSG 28 / POSYTIVE
Conditions: Synchronous Metastasized Breast Cancer, Circulating Tumor Cells
Keywords: breast cancer, ABCSG, POSYTIVE, growth factor, median survival, surgery on demand, surgical therapy, blood specimen
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Austrian Breast & Colorectal Cancer Study GroupResearch network
Collaborators: Bayer, Amgen, Hoffmann-La Roche, AstraZeneca, Sanofi, Wyeth-Lederle Pharma GmbH, GlaxoSmithKline, Merck Sharp & Dohme LLC, Fond of the Viennese Mayor
Study start: 24 Nov 2010 (actual)
Primary completion: Jul 2022 (actual)
Study completion: Jul 2022 (actual)
First posted: 18 Nov 2009 (estimated)
Results: Posted 19 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A: Surgical Therapy	Other	Procedure: SurgeryLocal therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory).
B: Surgery on Demand	Other	Procedure: Surgery on DemandIn Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients age ≥ 18 years
Eastern Cooperative Oncology Group Performance Status is 0 -2
Untreated synchronous metastasized invasive carcinoma of the breast with the primary tumor in situ (bilateral synchronous metastasized breast cancer patients are eligible)
The primary tumor must be identified and may be any size, however, primary resection with resection free margins must be possible
Invasive adenocarcinoma of the breast on histological examination

Key exclusion criteria (10 listed)

Patients in whom a R0 resection (microscopic free margins) is clinically questionable
Inflammatory cancer
Patients with a brain metastasis
Patients who are not eligible for general anesthesia and operations
Patients without metastatic breast cancer (patients with a tumor marker value (CEA, CA15-3) above normal levels without the radiological proven evidence of metastases are not eligible for the study)

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
Surgerylumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)	Procedure or surgery	A: Surgical Therapy
Surgery on Demandif necessary local therapy on demand	Procedure or surgery	B: Surgery on Demand

Primary outcome

Overall Survival (OS)
Time frame: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
Overall Survival with vs without local therapy (surgery)

2 secondary outcomes

Time to Distant Progression
Time frame: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
Time to Local Progression (TTPl)
Time frame: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months

Results and safety

Results posted to the registry on 19 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A: Surgical Therapy	45	8
B: Surgery on Demand	45	19

Primary outcome: Overall Survival (OS)

Time frame: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months. Median (95% Confidence Interval). Unit: months

Measure	A: Surgical Therapy n = 45	B: Surgery on Demand n = 45
Value	34.6 (25.4 to 47.9)	56.2 (34.0 to NA)

A: Surgical Therapy vs B: Surgery on Demand: Cox Proportional Hazard: 1.77 (95% CI 1.01 to 3.09), p = 0.042, Log Rank

Population analysed: Intent-to-treat population: All participants assigned to one of the two treatment arms were included in the analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Maximum observation period per patient for all-cause mortality was 10 years starting with randomization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A: Surgical Therapy	0 of 0	0 of 0	30 of 45
B: Surgery on Demand	0 of 0	0 of 0	22 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16614878Babiera GV, Rao R, Feng L, Meric-Bernstam F, Kuerer HM, Singletary SE, Hunt KK, Ross MI, Gwyn KM, Feig BW, Ames FC, Hortobagyi GN. Effect of primary tumor extirpation in breast cancer patients who present with stage IV disease and an intact primary tumor. Ann Surg Oncol. 2006 Jun;13(6):776-82. doi: 10.1245/ASO.2006.03.033. Epub 2006 Apr 17.
BackgroundBlanchard DK, Bhatia P, Hilsenbeck SG, Elledge RM. Does surgical management of stage IV breast cancer effect outcome? SABCC 2006, San Antonio
Background: PubMed 12559070Carmichael AR, Anderson ED, Chetty U, Dixon JM. Does local surgery have a role in the management of stage IV breast cancer? Eur J Surg Oncol. 2003 Feb;29(1):17-9. doi: 10.1053/ejso.2002.1339.
Background: PubMed 12407345Khan SA, Stewart AK, Morrow M. Does aggressive local therapy improve survival in metastatic breast cancer? Surgery. 2002 Oct;132(4):620-6; discussion 626-7. doi: 10.1067/msy.2002.127544.
Background: PubMed 16702580Rapiti E, Verkooijen HM, Vlastos G, Fioretta G, Neyroud-Caspar I, Sappino AP, Chappuis PO, Bouchardy C. Complete excision of primary breast tumor improves survival of patients with metastatic breast cancer at diagnosis. J Clin Oncol. 2006 Jun 20;24(18):2743-9. doi: 10.1200/JCO.2005.04.2226. Epub 2006 May 15.
Background: PubMed 17522944Gnerlich J, Jeffe DB, Deshpande AD, Beers C, Zander C, Margenthaler JA. Surgical removal of the primary tumor increases overall survival in patients with metastatic breast cancer: analysis of the 1988-2003 SEER data. Ann Surg Oncol. 2007 Aug;14(8):2187-94. doi: 10.1245/s10434-007-9438-0. Epub 2007 May 24.
Background: PubMed 12393820Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
Background: PubMed 12393819Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989.
Background: PubMed 16360786Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.
Background: PubMed 11759643Flanigan RC, Salmon SE, Blumenstein BA, Bearman SI, Roy V, McGrath PC, Caton JR Jr, Munshi N, Crawford ED. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med. 2001 Dec 6;345(23):1655-9. doi: 10.1056/NEJMoa003013.
Background: PubMed 11583750Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. doi: 10.1016/s0140-6736(01)06103-7.
Background: PubMed 16892025Norton L, Massague J. Is cancer a disease of self-seeding? Nat Med. 2006 Aug;12(8):875-8. doi: 10.1038/nm0806-875. No abstract available.
Individual participant dataSharing planned: No

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.

Florian Fitzal, MD study director

Austrian Breast & Colorectal Cancer Study Group

Michael Gnant, MD study director

Austrian Breast & Colorectal Cancer Study Group

Guenther Steger, MD study director

Austrian Breast & Colorectal Cancer Study Group

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 10 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 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Austria. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (OS) (time frame: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months). 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 NCT01015625, which also lists 31 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 19 Aug 2024.