Nasopharyngeal CarcinomaPhase 3NCT01245959

Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

A Phase 3 study testing Docetaxel, cisplatin and fluorouracil and Concurrent chemoradiotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The purpose of this study is to compare induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy in NPC patients. Read more about this study

Who is it for?: Ages 18 to 59 years
Conditions the study is for: Nasopharyngeal Carcinoma
What is being tested?: Docetaxel, cisplatin and fluorouracil and Concurrent chemoradiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 476 participants
Where: 1 siteChina
Study dates: Jan 2011to Apr 2018
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 59 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
Tumor staged as T3-4N1/N2-3 (according to the 7th American Joint Commission on Cancer edition).
No evidence of distant metastasis (M0).
Satisfactory performance status: Karnofsky scale (KPS) > 70.
Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
Adequate renal function: creatinine clearance ≥60 ml/min.
Patients must be informed of the investigational nature of this study and give written informed consent.

Who cannot join

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Age ≥60 years or <18 years.
Treatment with palliative intent.
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Pregnancy or lactation.
History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Read the detailed description

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Patients in the investigational arm receive docetaxel(60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy. Patients are stratified according to the treatment centers and stage. The primary end point is failure-free survival (FFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.

Conditions: Nasopharyngeal Carcinoma
Being tested: Docetaxel, cisplatin and fluorouracil, Concurrent chemoradiotherapy
Keywords: Nasopharyngeal carcinoma, Concurrent chemoradiotherapy, Induction chemotherapy, Clinical trial
Medical subject headings: Nasopharyngeal Carcinoma

What participants receive

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

Docetaxel, cisplatin and fluorouracilDrug
Also called TPF induction chemotherapy
Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
Concurrent chemoradiotherapyRadiation
Also called Radical radiotherapy and concurrent cisplatin
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Study groups in NCT01245959
Study group	Role	What they receive
Induction chemotherapy and concurrent chemoradiotherapy	Experimental	Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Receives: Drug: Docetaxel, cisplatin and fluorouracil; Radiation: Concurrent chemoradiotherapy
Concurrent chemoradiotherapy	Active comparator	Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Receives: Radiation: Concurrent chemoradiotherapy

What is being measured

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

Failure-free survival
Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
Measured: 3-year

Secondary outcomes (5)

Overall survival
Overall survival is calculated from randomization to death from any cause.
Measured: 3-year
Locoregional failure-free survival
The latency (ie, time from randomisation) to the first locoregional failure
Measured: 3-year
Distant failure-free survival
The latency (ie, time from randomisation) to the first remote failure
Measured: 3-year
The initial response rates after treatments
Measured: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy
Toxic effects
Measured: During and after treatment

Timeline

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

Jan 2011Apr 2018

First posted23 Nov 2010 (estimated)
Study startJan 2011
Primary completionApr 2016 (estimated)
Study completionApr 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
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: 476 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01245959
Sponsor's protocol ID: YP2010171
Status last verified: Jan 2014
First submitted: 22 Nov 2010
Last updated: 13 Feb 2014
Results posted: No
Data monitoring committee: Yes

Publications

Cancer incidence in five continents. Volume VIII. IARC Sci Publ. 2002;(155):1-781. No abstract available.
PubMed 12812229
Stephen B. Edge, David R. Byrd, Carolyn C. Compton, April G. Fritz, Frederick L. Greene, and Andy Trotti. AJCC Cancer Staging Manual. 7th ed. New York: Springer, 2009: 41-46.
Lai SZ, Li WF, Chen L, Luo W, Chen YY, Liu LZ, Sun Y, Lin AH, Liu MZ, Ma J. How does intensity-modulated radiotherapy versus conventional two-dimensional radiotherapy influence the treatment results in nasopharyngeal carcinoma patients? Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):661-8. doi: 10.1016/j.ijrobp.2010.03.024. Epub 2010 Jul 17.
PubMed 20643517
Baujat B, Audry H, Bourhis J, Chan AT, Onat H, Chua DT, Kwong DL, Al-Sarraf M, Chi KH, Hareyama M, Leung SF, Thephamongkhol K, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy in locally advanced nasopharyngeal carcinoma: an individual patient data meta-analysis of eight randomized trials and 1753 patients. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):47-56. doi: 10.1016/j.ijrobp.2005.06.037.
PubMed 16377415
Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.
PubMed 17960012
Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.
PubMed 17960013
Qin-Hua Zhang, Wei Luo, Qi-Chao Zhou, Zhan Yu, Jun Ma, Meng-Zhong Liu. TPF induction chemotherapy followed by intensity-modulated radiotherapy and concomitant chemotherapy for locoregionally advanced nasopharyngeal carcinoma. Chinese Journal of Cancer Prevention and Treatment 16(8): 625-628, 2009.
Guo L, Lin HX, Xu M, Chen QY, Wang CT, Huang PY. Phase I study of TPF neoadjuvant chemotherapy followed by radical radiotherapy in advanced nasopharyngeal carcinoma. Chin J Cancer. 2010 Feb;29(2):136-9. doi: 10.5732/cjc.009.10367.
PubMed 20109339
Friedman J, Furberg, C, DeMets D. Fundamentals of clinical trials. New York: Springer-Verlag; 1998.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774
Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available.
PubMed 7713792
Chow, S.C., Shao, J., Wang, H. Sample Size Calculations in Clinical Research. New York: Marcel Dekker; 2003.
Dong D, Zhang F, Zhong LZ, Fang MJ, Huang CL, Yao JJ, Sun Y, Tian J, Ma J, Tang LL. Development and validation of a novel MR imaging predictor of response to induction chemotherapy in locoregionally advanced nasopharyngeal cancer: a randomized controlled trial substudy (NCT01245959). BMC Med. 2019 Oct 23;17(1):190. doi: 10.1186/s12916-019-1422-6.
PubMed 31640711
Zhang Y, Li WF, Liu X, Chen L, Sun R, Sun Y, Liu Q, Ma J. Nomogram to predict the benefit of additional induction chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: Analysis of a multicenter, phase III randomized trial. Radiother Oncol. 2018 Oct;129(1):18-22. doi: 10.1016/j.radonc.2017.12.002. Epub 2017 Dec 16.
PubMed 29258695
Li WF, Chen L, Sun Y, Ma J. Induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma. Chin J Cancer. 2016 Nov 15;35(1):94. doi: 10.1186/s40880-016-0157-4.
PubMed 27846913

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nasopharyngeal Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT01245959
Acronym / sponsor ID: YP2010171
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma, Concurrent chemoradiotherapy, Induction chemotherapy, Clinical trial
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 476 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Collaborators: Fudan University, West China Hospital, Huazhong University of Science and Technology, Peking University Cancer Hospital & Institute, Zhejiang Cancer Hospital, Central South University, Jiangsu Cancer Institute & Hospital, First People's Hospital of Foshan, The Third Affiliated Hospital of Harbin Medical University, Cancer Hospital of Guangxi Medical University, Jiangxi Provincial Cancer Hospital, Guangzhou Medical University
Study start: Jan 2011
Primary completion: Apr 2016 (estimated)
Study completion: Apr 2018 (estimated)
First posted: 23 Nov 2010 (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.

Detailed description

Study design

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

Arm	Type	Receives
Induction chemotherapy and concurrent chemoradiotherapy	Experimental	Drug: Docetaxel, cisplatin and fluorouracil, Radiation: Concurrent chemoradiotherapyPatients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Concurrent chemoradiotherapy	Active comparator	Radiation: Concurrent chemoradiotherapyPatients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
Tumor staged as T3-4N1/N2-3 (according to the 7th American Joint Commission on Cancer edition).
No evidence of distant metastasis (M0).
Satisfactory performance status: Karnofsky scale (KPS) > 70.
Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.

Key exclusion criteria (8 listed)

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Age ≥60 years or <18 years.
Treatment with palliative intent.
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Pregnancy or lactation.

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
Docetaxel, cisplatin and fluorouracilAlso: TPF induction chemotherapyPatients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.	Drug	Induction chemotherapy and concurrent chemoradiotherapy
Concurrent chemoradiotherapyAlso: Radical radiotherapy and concurrent cisplatinPatients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.	Radiation	Concurrent chemoradiotherapy, Induction chemotherapy and concurrent chemoradiotherapy

Primary outcome

Failure-free survival
Time frame: 3-year
Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

5 secondary outcomes

Overall survival
Time frame: 3-year
Locoregional failure-free survival
Time frame: 3-year
Distant failure-free survival
Time frame: 3-year
The initial response rates after treatments
Time frame: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy
Toxic effects
Time frame: During and after treatment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
Background: PubMed 12812229Cancer incidence in five continents. Volume VIII. IARC Sci Publ. 2002;(155):1-781. No abstract available.
BackgroundStephen B. Edge, David R. Byrd, Carolyn C. Compton, April G. Fritz, Frederick L. Greene, and Andy Trotti. AJCC Cancer Staging Manual. 7th ed. New York: Springer, 2009: 41-46.
Background: PubMed 20643517Lai SZ, Li WF, Chen L, Luo W, Chen YY, Liu LZ, Sun Y, Lin AH, Liu MZ, Ma J. How does intensity-modulated radiotherapy versus conventional two-dimensional radiotherapy influence the treatment results in nasopharyngeal carcinoma patients? Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):661-8. doi: 10.1016/j.ijrobp.2010.03.024. Epub 2010 Jul 17.
Background: PubMed 16377415Baujat B, Audry H, Bourhis J, Chan AT, Onat H, Chua DT, Kwong DL, Al-Sarraf M, Chi KH, Hareyama M, Leung SF, Thephamongkhol K, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy in locally advanced nasopharyngeal carcinoma: an individual patient data meta-analysis of eight randomized trials and 1753 patients. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):47-56. doi: 10.1016/j.ijrobp.2005.06.037.
Background: PubMed 17960012Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.
Background: PubMed 17960013Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.
BackgroundQin-Hua Zhang, Wei Luo, Qi-Chao Zhou, Zhan Yu, Jun Ma, Meng-Zhong Liu. TPF induction chemotherapy followed by intensity-modulated radiotherapy and concomitant chemotherapy for locoregionally advanced nasopharyngeal carcinoma. Chinese Journal of Cancer Prevention and Treatment 16(8): 625-628, 2009.
Background: PubMed 20109339Guo L, Lin HX, Xu M, Chen QY, Wang CT, Huang PY. Phase I study of TPF neoadjuvant chemotherapy followed by radical radiotherapy in advanced nasopharyngeal carcinoma. Chin J Cancer. 2010 Feb;29(2):136-9. doi: 10.5732/cjc.009.10367.
BackgroundFriedman J, Furberg, C, DeMets D. Fundamentals of clinical trials. New York: Springer-Verlag; 1998.
Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
Background: PubMed 7713792Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6. doi: 10.1016/0360-3016(95)00060-C. No abstract available.
BackgroundChow, S.C., Shao, J., Wang, H. Sample Size Calculations in Clinical Research. New York: Marcel Dekker; 2003.

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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.

Jun Ma, M.D. study chair

Sun Yat-Sen University Cancer Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, cisplatin and fluorouracil and Concurrent chemoradiotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

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 8 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: status not confirmed, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Results are not available in the source record.

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?

Failure-free survival (time frame: 3-year). 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 NCT01245959, which also lists 16 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 13 Feb 2014.