Breast CancerPhase 3NCT01452672
Resource-sparing Post-mastectomy Radiotherapy in Breast Cancer
A Phase 3 study testing Radiotherapy and Irradiation of the chest-wall and supraclavicular fossa in people with Breast Cancer, run by International Atomic Energy Agency at 9 sites in 8 countries.
Trial summary
This study compares two different field set-ups in patients with breast cancer following a breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa. Read more about this study
- Who is it for?
- Ages 18 to 81 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiotherapy and Irradiation of the chest-wall and supraclavicular fossa
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 9 sitesin 8 countries
- Study dates
- Mar 2007to Dec 2012
- 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 81 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be older than 18 and less than 81 years of age
- WHO (ECOG) Performance Status of 0-2
- Histologically confirmed diagnosis of infiltrating ductal carcinoma of the breast, lobular carcinoma or mixed (ductal and lobular) type.
- Note: Tumor diagnosis will be performed at the participating center according to the center's routine procedures.
- Patients must have had a modified radical mastectomy (MRM) in which 6 or more axillary nodes were removed.
- All patients should receive adjuvant chemotherapy following MRM. The initiation of radiation therapy must allow for the full recovery of blood counts (WBC > 3.0 x 109/L, Granulocytes > 1.5 x109/L and platelets > 75 x 109/L).
Show all 20Show fewer
- Note: MRM should have been performed at maximum 3 months prior to the start of adjuvant chemotherapy.
- Special Note: Patients who have not received adjuvant chemotherapy will be required to receive adjuvant chemotherapy as per Appendix 3 prior to study entry and initiation of radiotherapy must allow for the full recovery of blood counts (WBC > 3.0 x 109/L, Granulocytes > 1.5 x109/L and platelets > 75 x 109/L MRM should have been performed within 3 months prior to the start of adjuvant chemotherapy.
- Patients must have received adjuvant chemotherapy according to one of the two regimens found in Appendix 3.
- Negative surgical margins by histopathology at the time of MRM. Note: Negative surgical margins means that there are no cancer cells at the inked margin of resection or otherwise at the margins of the mastectomy specimen.
- The following indicators in the histological samples must be known :
- Tumor size
- Tumor site (quadrant, central, axillary tail)
- Presence of extensive intraductal component (EIC)
- Estrogen and Progesterone Receptor Status and the method of staining and detection.
- HER2 Status (optional), if given, the method must be provided.
- Patients with the following TNM stages, all being M0: pT1 N1, pT2 N1, pT3 N0, pT0 N2, pT1 N2, pT2 N2, T3 N1, pT3 N2 (see Appendix 4 for TNM Stage)
- Histological grades 1 - 3 (as per WHO criteria)
- Patients must consent to return for scheduled treatments and follow up.
- Written informed consent document signed
Who cannot join
- Pathological pN3 (metastasis in 10 or more lymph nodes, clinically apparent internal mammary metastasis, metastasis in the supraclavicular lymph nodes)
- Stages IIIB, IIIC and IV (any T4, any N3 or M1)
- Recurrence of breast cancer following MRM and/or adjuvant chemotherapy.
- Concomitant primary cancer in the contralateral breast.
- History of other malignancy except carcinoma in situ of the cervix or non-melanoma skin cancer
- Pregnant or breast-feeding
Show all 10Show fewer
- Previous chemotherapy other than adjuvant chemotherapy for treatment of the present breast cancer
- Other severe concomitant disease that could impact upon the ability to deliver treatment or increase the risk of toxicity (such as uncompensated congestive heart failure, unstable coronary heart disease, uncompensated chronic obstructive pulmonary disease, collagen vascular diseases including systemic lupus erythematosus, systemic sclerosis, dermatomyositis, and ataxia telangiectasia).
- Contraindications to radiation therapy (such as previous irradiation of the breast or chest wall)
- Severe psychiatric disorder that may interfere with the process of informed consent and/or treatment or follow-up compliance.
Trial locations and contacts
9 sites in 8 countries.
9 sites in 8 countries
Egypt2 sites, 2 recruiting
- Recruiting
Alexandria Ayadi Almostakbal Oncology Cenre.
Alexandria
Ahmed Elzawawy, MD, +20-66-33-32-758, icedoc@nilesat.net
Ahmed Elsawawy, MD
- Recruiting
Cairo National Cancer Institute
Cairo, Fom El-Khalig, 11796
Magda M. El-Mongy, MD, +20-101-714805, magdamongi@yahoo.com
Magda M. El-Mongy, MD
Cuba1 site, 1 recruiting
- Recruiting
Instituto Naciolal de Oncologia y Radiobiologia (INOR)
Havana, 10400
Jorge M. Marinello, MD, poliva@infomed.sld.cu
Jorge M. Marinello, MD
Ghana1 site, 1 recruiting
- Recruiting
Korle Bu Teaching Hospital
Accra
Verna Vanderpuye, MD, +233-21-676222/669202, vanaglat@yahoo.com
Verna Vanderpuye, MD
Morocco1 site, 1 recruiting
- Recruiting
Institut National d'Oncologie
Rabat, 10100
Mansouri Aziz, MD, a.mansouri@gmx.net
Mansouri Aziz, MD
Nigeria1 site, 1 recruiting
- Recruiting
University of Ibadan College Hospital
Ibadan
Oladapo B. Campbell, MD, +234-803, dapocampbell@yahoo.com
Oladapo B. Campbell, MD
Pakistan1 site, 1 recruiting
- Recruiting
Institut of Radiotherapy and Nuclear Medicine (IRNUM)
Peshawar, 25120
Safoora Shahid, MD, 0092-91-9216114, irnum@psh.paknet.com.pk
Safoora Shahid, MD
Peru1 site, 1 recruiting
- Recruiting
Instituto Nacional de Enfermedades Neoplasicas
Lima, 34
Jorge A. Moscol_Ledesma, MD, +51-1-4499137, jamoscol@hotmail.com
Jorge A. Moscol-Ledesma, MD
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cerraphasa Medical Faculty
Istanbul, 34303
Nuran Bese, MD, +90-532-4680805, nuranbese@superonline.com
Nuran Bese, MD
About this study
Official title: Resource-sparing Radiotherapy for Breast Cancer
This study compares two different field set-ups in patients with breast cancer following a breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa.
Patients in both treatment arms will receive radiotherapy with a shortened fractionation schedule.
Study hypothesis: irradiation of the chest-wall only is not inferior to irradiation of the chest-wall and supraclavicular fossa in terms of loco-regional control, survival and treatment toxicity.
Read the detailed description
Post-mastectomy radiotherapy (PMRT) substantially reduces the risk of loco- regional failure as shown in several studies and meta-analyses. Two large trials for pre-menopausal node-positive breast cancer patients treated with mastectomy and chemotherapy showed that PMRT not only reduced loco- regional failure rates but also improved disease-free and overall survival rates.
Although the benefit of PMRT is clear, the optimal volume of tissues to be covered by the radiotherapy fields is controversial. Since the chest wall is the most likely location of recurrence, there is uniform consensus that the chest wall should be irradiated. However, areas of controversy exist regarding irradiation of the regional lymph nodes (axillary, supraclavicular and internal mammary lymph nodes), optimal radiation dose, and dose-fractionation.
If equivalent results could be achieved by omitting irradiation of the supraclavicular region in patients receiving adjuvant systemic therapy, this will simplify and expedite treatment in this patient population. Furthermore, the use of a shortened fractionation schedule of 40 Gy in 15 fractions (2.67 Gy per fraction) over 3 weeks which has been used in the UK and Canada for post-mastectomy patients for several decades will shorten the duration of treatment by reducing the number of patient visits for radiotherapy and increase the number of patients who can be treated. Treatment will be more convenient for patients and a reduction in the number of treatments could result in savings for strained health care systems.
This is a randomized comparison of two different radiotherapy field set-ups for post-mastectomy treatment of locally advanced breast cancer. Patients who have undergone modified radical mastectomy including axillary lymph node dissection will be randomized to receive one of two radiotherapy treatment arms, A and B following the completion of adjuvant chemotherapy. The radiotherapy for treatment Arm A consists of irradiation of the chest wall only while Treatment Arm B includes irradiation of the chest wall and the ipsilateral supraclavicular field. Patients on both treatment arms will receive radiation with a shortened fractionation schedule. Patients will be evaluated for local control, regional control, survival and treatment toxicity.
- Conditions
- Breast Cancer
- Being tested
- Radiotherapy, Irradiation of the chest-wall and supraclavicular fossa
- Keywords
- Breast cancer, Radiotherapy, Post-mastectomy, Molecular characterization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
RT 40 Gy in 15 fractions
Irradiation of the chest-wall and supraclavicular fossaRadiation
RT 40Gy in 15 fractions
| Study group | Role | What they receive |
|---|---|---|
| RT to chest wall and S/C | Active comparator | Irradiation of the chest-wall and supraclavicular fossa Receives: Radiation: Irradiation of the chest-wall and supraclavicular fossa |
| RT to chest wall | Experimental | Irradiation of the chest-wall alone Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control.
The presence/absence of recurrent disease in the surgical scar, ipsilateral chest wall, ipsilateral skin and soft tissue.
Measured: 4 years
Regional control.
The presence/absence of recurrent disease in the axilla, ipsilateral supraclavicular/infraclavicular nodes and or ipsilateral skin/soft tissue in the regional areas.
Measured: 4 years
Overall survival.
Measured: 4 years
Disease-free survival.
Measured: 4 years
Acute adverse events.
During treatment and up to 90 days following the completion of treatment.
Measured: 4 years
Late adverse events.
More than 90 days after the completion of radiation therapy.
Measured: 4 years
Secondary outcomes (4)
Patients' demographics.
Measured: 4 years
Reproductive history.
Number of pregnancies, miscarriages. Menstrual History.
Measured: 1 year
Family history.
Family history of breast cancer.
Measured: 1 year
Characterization of molecular profile of breast cancer patients.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startMar 2007
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Atomic Energy Agency
- Sponsor type
- Other government
- Collaborators
- International Network for Cancer Treatment and Research
- Responsible party
- Sponsor
- Investigators
- Eduardo Rosenblatt, MD, Study chair, International Atomic Energy Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452672
- Sponsor's protocol ID
- E3.30.25
- Status last verified
- Oct 2011
- First submitted
- 10 Oct 2011
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nielsen HM, Overgaard M, Grau C, Jensen AR, Overgaard J. Loco-regional recurrence after mastectomy in high-risk breast cancer--risk and prognosis. An analysis of patients from the DBCG 82 b&c randomization trials. Radiother Oncol. 2006 May;79(2):147-55. doi: 10.1016/j.radonc.2006.04.006. Epub 2006 Apr 27.
PubMed 16647152Adenipekun A, Campbell OB, Oyesegun AR, Elumelu TN. Radiotherapy in the management of early breast cancer in Ibadan: outcome of chest wall irradiation alone in clinically nodes free axilla. Afr J Med Med Sci. 2002 Dec;31(4):345-7.
PubMed 15027777Truong PT, Olivotto IA, Whelan TJ, Levine M; Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: 16. Locoregional post-mastectomy radiotherapy. CMAJ. 2004 Apr 13;170(8):1263-73. doi: 10.1503/cmaj.1031000.
PubMed 15078851Owen JR, Ashton A, Bliss JM, Homewood J, Harper C, Hanson J, Haviland J, Bentzen SM, Yarnold JR. Effect of radiotherapy fraction size on tumour control in patients with early-stage breast cancer after local tumour excision: long-term results of a randomised trial. Lancet Oncol. 2006 Jun;7(6):467-71. doi: 10.1016/S1470-2045(06)70699-4.
PubMed 16750496Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143.
PubMed 12165639
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resource-sparing Radiotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT01452672
- Acronym / sponsor ID
- E3.30.25
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Radiotherapy, Post-mastectomy, Molecular characterization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- International Atomic Energy AgencyOther government
- Collaborators
- International Network for Cancer Treatment and Research
- Study start
- Mar 2007
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 17 Oct 2011 (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.
This study compares two different field set-ups in patients with breast cancer following a breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa.
Patients in both treatment arms will receive radiotherapy with a shortened fractionation schedule.
Study hypothesis: irradiation of the chest-wall only is not inferior to irradiation of the chest-wall and supraclavicular fossa in terms of loco-regional control, survival and treatment toxicity.
Detailed description
Post-mastectomy radiotherapy (PMRT) substantially reduces the risk of loco- regional failure as shown in several studies and meta-analyses. Two large trials for pre-menopausal node-positive breast cancer patients treated with mastectomy and chemotherapy showed that PMRT not only reduced loco- regional failure rates but also improved disease-free and overall survival rates.
Although the benefit of PMRT is clear, the optimal volume of tissues to be covered by the radiotherapy fields is controversial. Since the chest wall is the most likely location of recurrence, there is uniform consensus that the chest wall should be irradiated. However, areas of controversy exist regarding irradiation of the regional lymph nodes (axillary, supraclavicular and internal mammary lymph nodes), optimal radiation dose, and dose-fractionation.
If equivalent results could be achieved by omitting irradiation of the supraclavicular region in patients receiving adjuvant systemic therapy, this will simplify and expedite treatment in this patient population. Furthermore, the use of a shortened fractionation schedule of 40 Gy in 15 fractions (2.67 Gy per fraction) over 3 weeks which has been used in the UK and Canada for post-mastectomy patients for several decades will shorten the duration of treatment by reducing the number of patient visits for radiotherapy and increase the number of patients who can be treated. Treatment will be more convenient for patients and a reduction in the number of treatments could result in savings for strained health care systems.
This is a randomized comparison of two different radiotherapy field set-ups for post-mastectomy treatment of locally advanced breast cancer. Patients who have undergone modified radical mastectomy including axillary lymph node dissection will be randomized to receive one of two radiotherapy treatment arms, A and B following the completion of adjuvant chemotherapy. The radiotherapy for treatment Arm A consists of irradiation of the chest wall only while Treatment Arm B includes irradiation of the chest wall and the ipsilateral supraclavicular field. Patients on both treatment arms will receive radiation with a shortened fractionation schedule. Patients will be evaluated for local control, regional control, survival and treatment toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT to chest wall and S/C | Active comparator | Radiation: Irradiation of the chest-wall and supraclavicular fossaIrradiation of the chest-wall and supraclavicular fossa |
| RT to chest wall | Experimental | Radiation: RadiotherapyIrradiation of the chest-wall alone |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients must be older than 18 and less than 81 years of age
- WHO (ECOG) Performance Status of 0-2
- Histologically confirmed diagnosis of infiltrating ductal carcinoma of the breast, lobular carcinoma or mixed (ductal and lobular) type.
- Note: Tumor diagnosis will be performed at the participating center according to the center's routine procedures.
- Patients must have had a modified radical mastectomy (MRM) in which 6 or more axillary nodes were removed.
Key exclusion criteria (10 listed)
- Pathological pN3 (metastasis in 10 or more lymph nodes, clinically apparent internal mammary metastasis, metastasis in the supraclavicular lymph nodes)
- Stages IIIB, IIIC and IV (any T4, any N3 or M1)
- Recurrence of breast cancer following MRM and/or adjuvant chemotherapy.
- Concomitant primary cancer in the contralateral breast.
- History of other malignancy except carcinoma in situ of the cervix or non-melanoma skin cancer
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 |
|---|---|---|
| RadiotherapyRT 40 Gy in 15 fractions | Radiation | RT to chest wall |
| Irradiation of the chest-wall and supraclavicular fossaRT 40Gy in 15 fractions | Radiation | RT to chest wall and S/C |
Primary outcome
Local control.
Time frame: 4 years
The presence/absence of recurrent disease in the surgical scar, ipsilateral chest wall, ipsilateral skin and soft tissue.
Regional control.
Time frame: 4 years
The presence/absence of recurrent disease in the axilla, ipsilateral supraclavicular/infraclavicular nodes and or ipsilateral skin/soft tissue in the regional areas.
Overall survival.
Time frame: 4 years
Disease-free survival.
Time frame: 4 years
Acute adverse events.
Time frame: 4 years
During treatment and up to 90 days following the completion of treatment.
Late adverse events.
Time frame: 4 years
More than 90 days after the completion of radiation therapy.
4 secondary outcomes
Patients' demographics.
Time frame: 4 years
Reproductive history.
Time frame: 1 year
Family history.
Time frame: 1 year
Characterization of molecular profile of breast cancer patients.
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
- Background: PubMed 16647152Nielsen HM, Overgaard M, Grau C, Jensen AR, Overgaard J. Loco-regional recurrence after mastectomy in high-risk breast cancer--risk and prognosis. An analysis of patients from the DBCG 82 b&c randomization trials. Radiother Oncol. 2006 May;79(2):147-55. doi: 10.1016/j.radonc.2006.04.006. Epub 2006 Apr 27.
- Background: PubMed 15027777Adenipekun A, Campbell OB, Oyesegun AR, Elumelu TN. Radiotherapy in the management of early breast cancer in Ibadan: outcome of chest wall irradiation alone in clinically nodes free axilla. Afr J Med Med Sci. 2002 Dec;31(4):345-7.
- Background: PubMed 15078851Truong PT, Olivotto IA, Whelan TJ, Levine M; Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: 16. Locoregional post-mastectomy radiotherapy. CMAJ. 2004 Apr 13;170(8):1263-73. doi: 10.1503/cmaj.1031000.
- Background: PubMed 16750496Owen JR, Ashton A, Bliss JM, Homewood J, Harper C, Hanson J, Haviland J, Bentzen SM, Yarnold JR. Effect of radiotherapy fraction size on tumour control in patients with early-stage breast cancer after local tumour excision: long-term results of a randomised trial. Lancet Oncol. 2006 Jun;7(6):467-71. doi: 10.1016/S1470-2045(06)70699-4.
- Background: PubMed 12165639Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143.
- International Atomic Energy AgencyLink provided by the sponsor.
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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.
Eduardo Rosenblatt, MD study chair
International Atomic Energy Agency
9 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy and Irradiation of the chest-wall and supraclavicular fossa in people with Breast Cancer, run by International Atomic Energy Agency at 9 sites in 8 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 20 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: status not confirmed, as of the sponsor's last update on 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Egypt, Cuba, Ghana, Morocco, Nigeria and 3 more countries. 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?
Contact Eduardo Rosenblatt, MD ((43 1) 2600-21669 ext. 21669, e.rosenblatt@iaea.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control. (time frame: 4 years). The study lists 6 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 NCT01452672, which also lists 5 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 17 Oct 2011.