Breast CancerNCT02648802
Cavity Shaving in Breast Conserving Surgery for Breast Cancer Patients
A study testing Cavity shaving and Standardized BCS+CM assessment. in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This randomized controlled trial is to evaluate the impact of additional cavity shaving (CS) on pathological cavity margin (CM) status in breast cancer patients. Patients receiving standard breast-conserving surgery (BCS) will be randomized to intra-operative CM assessment versus intra-operative CS followed by CM… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cavity shaving and Standardized BCS+CM assessment.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to 20 Aug 2019
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- At least 18 years of age and no more than 65 years of age
- Able to understand and willing to sign an informed consent document
- Willing and planning to undergo the breast-conserving surgery
- ECOG≤ 2
Who cannot join
- Inflammatory breast cancer
- Preference for mastectomy instead of breast-conserving surgery
- Necessity to undergo oncoplastic breast surgery
- Prior surgical treatment, including ultrasound-guided vacuum-assisted biopsy and excision biopsy.
- Prior systemic therapy for this diagnosis, including neoadjuvant chemotherapy, neoadjuvant endocrine therapy.
- History of prior breast/axillary radiation therapy
Show all 16Show fewer
- Known metastatic disease
- Diagnosed as bilateral breast cancer or DCIS
- History of other malignancy ≤ 5 years previous
- Preoperation evaluation indicates tumor size>5cm
- Preoperation evaluation indicates multicenter or multifocal breast cancer(including suspicious calcification on mammography)
- Undergoing other clinical trials
- With sever liver disfunction(Child-Pugh C)
- With sever cardiac insufficiency
- With sever renal disfunction
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
Guangzhou, Guangdong, 510120
About this study
Official title: Cavity Shaving in Breast Conserving Surgery With Intraoperative Cavity Margin Assessment: A Single Center,Randomized,Controlled Trial
This randomized controlled trial is to evaluate the impact of additional cavity shaving (CS) on pathological cavity margin (CM) status in breast cancer patients. Patients receiving standard breast-conserving surgery (BCS) will be randomized to intra-operative CM assessment versus intra-operative CS followed by CM assessment. The primary objective of this study is to assess the impact of CS on intra-operative CM status, intra-operative re-excision rate, post-operative CM status and re-excision rate, cosmetic outcomes, and on intraoperative time and medical costs.
Read the detailed description
After stratified and blocked randomization, the patients' name, admission ID and treatment assignment will be written on a slip of paper, and will be placed in a sealed envelop. A label with the patients' name and admission ID will be placed on the sealed envelop, which will be kept in a locked file. On the day of surgery, a research coordinator will bring the sealed envelope to the operation room. During the standard-of-care BCS, the tumor was excised with a rim of grossly normal tissue. Additional resections are allowed when any of the margins of the tumor-containing specimen were suspected to be inadequate on the basis of standard gross evaluation by surgeons. Prior to intra-operative CM assessment, the research co-ordinator will unseal the envelop and determine which procedure has been designated to the patient. The cosmetic outcome and the quality of life will be evaluated at the day of discharge, after completion of radiotherapy and one year by the patient herself, her partner and a research co-ordinator.
- Conditions
- Breast Cancer
- Being tested
- Cavity shaving, Standardized BCS+CM assessment.
- Keywords
- breast-conserving surgery(BCS), Cavity shave margin, Proportion of positive margins
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cavity shavingProcedure or surgery
Resect the residual cavity circumferentially (superior, inferior, medial, lateral) and the thickness of the cavity shaving depends on the surgeon's discretion (Recommended 0.5-1.0cm). The principles of the cavity shaving includes: 1) do not compromise the cosmetic outcomes; 2) covers the entire cavity;
Standardized BCS+CM assessment.Procedure or surgery
For standardized BCS(Chen K, et al. Ann Surg Oncol. 2012), we resect a rim of 1 cm macroscopically normal tissue around the tumor. The anterior and posterior margins of the tumor-containing specimen extended up to the subdermal plane of the skin and down to the pectoralis major fascia, respectively. The anterior and posterior CMs assessment will not be needed. A surgical blade was used for resecting the CMs (superior, inferior, medial and lateral) to render the thickness of the CMs as thin as possible. No procedures were required for distinguishing the inner and outer surface. They were then frozen and cut parallel, but not perpendicular to the largest surface area. CMs were defined as positive when in situ or invasive carcinoma was found intraoperatively by frozen-section analysis.
| Study group | Role | What they receive |
|---|---|---|
| Cavity shaving and CM assessment | Experimental | Standardized BCS with additional cavity shaving before CM assessment. Receives: Procedure: Cavity shaving; Procedure: Standardized BCS+CM assessment. |
| CM assessment | Placebo comparator | Standardized BCS with CM assessment. Receives: Procedure: Standardized BCS+CM assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity rate of CMs by intraoperative frozen section analysis.
Proportion of patients with at least one positive(invasive carcinoma or carcinoma in situ, excluding LCIS) CMs on intraoperative frozen section analysis
Measured: Completion of surgery for all enrolled patients (approximately 12 months)
Secondary outcomes (9)
Intra-operative rate of suspected/positive CM
Proportion of patients with at least one positive(invasive carcinoma or carcinoma in situ, excluding LCIS) or suspected CMs on intraoperative frozen section analysis. Suspected CMs were defined as CMs with severe atypical hyperplasia observed by frozen section analysis.
Measured: Completion of surgery for all enrolled patients (approximately 12 months)
Rate of intra-operative re-excision for suspected/positive CMs
For patients with positive CMs, intra-operative re-excision was required. For patients with suspected CMs,intra-operative re-excision is left to the surgeon's discretion
Measured: Completion of surgery for all enrolled patients (approximately 12 months)
Rate of a second-time surgery for post-operative positive CMs
Positive CMs by post-operative pathological analysis may require a second-time surgery for re-excision.
Measured: Completion of surgery for all enrolled patients (approximately 12 months)
Proportion of patients successfully undergone BCT
Measured: Completion of surgery for all enrolled patients (approximately 12 months)
Cost-effectiveness of cavity shaving in BCS as measured by operative time of the surgery
Surgery time(start from making the incision to closure) will be analyzed.
Measured: Completion of surgery for all enrolled patients (approximately 12 months)
Cost-effectiveness of cavity shaving in BCS as measured by medical cost of the surgery
Medical costs will be analyzed.
Measured: Completion of surgery for all enrolled patients (approximately 12 months)
Cosmetic outcome
Patients', partners' and physicians' perceptions of the cosmetic outcomes as measured by Harvard/NSABP/RTOG criteria
Measured: One year after surgery.
Adverse events
Measured: One year after surgery.
Quality of life.
Chinese version of validated QLQ-C30 and QLQ-BR23 questionnaire
Measured: One year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2018
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Fengxi Su, M.D., Principal investigator, Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648802
- Sponsor's protocol ID
- CSBCS1
- Status last verified
- Aug 2019
- First submitted
- 3 Jan 2016
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The de-identified individual participant data will be available after the research paper has been published.
Publications
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 12393820Veronesi 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 12393819Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chavez-MacGregor M, Freedman G, Houssami N, Johnson PL, Morrow M. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. Int J Radiat Oncol Biol Phys. 2014 Mar 1;88(3):553-64. doi: 10.1016/j.ijrobp.2013.11.012.
PubMed 24521674Morrow M, Jagsi R, Alderman AK, Griggs JJ, Hawley ST, Hamilton AS, Graff JJ, Katz SJ. Surgeon recommendations and receipt of mastectomy for treatment of breast cancer. JAMA. 2009 Oct 14;302(14):1551-6. doi: 10.1001/jama.2009.1450.
PubMed 19826024Cendan JC, Coco D, Copeland EM 3rd. Accuracy of intraoperative frozen-section analysis of breast cancer lumpectomy-bed margins. J Am Coll Surg. 2005 Aug;201(2):194-8. doi: 10.1016/j.jamcollsurg.2005.03.014.
PubMed 16038815Chagpar AB, Killelea BK, Tsangaris TN, Butler M, Stavris K, Li F, Yao X, Bossuyt V, Harigopal M, Lannin DR, Pusztai L, Horowitz NR. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015 Aug 6;373(6):503-10. doi: 10.1056/NEJMoa1504473. Epub 2015 May 30.
PubMed 26028131Kayar R, Civelek S, Cobanoglu M, Gungor O, Catal H, Emiroglu M. Five methods of breast volume measurement: a comparative study of measurements of specimen volume in 30 mastectomy cases. Breast Cancer (Auckl). 2011 Mar 27;5:43-52. doi: 10.4137/BCBCR.S6128.
PubMed 21494401Chen K, Zeng Y, Jia H, Jia W, Yang H, Rao N, Song E, Cox CE, Su F. Clinical outcomes of breast-conserving surgery in patients using a modified method for cavity margin assessment. Ann Surg Oncol. 2012 Oct;19(11):3386-94. doi: 10.1245/s10434-012-2331-5. Epub 2012 Apr 10.
PubMed 22488098Chen K, Zhu L, Chen L, Li Q, Li S, Qiu N, Yang Y, Su F, Song E. Circumferential Shaving of the Cavity in Breast-Conserving Surgery: A Randomized Controlled Trial. Ann Surg Oncol. 2019 Dec;26(13):4256-4263. doi: 10.1245/s10434-019-07725-w. Epub 2019 Aug 19.
PubMed 31429019
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cavity Shaving in Breast Conserving Surgery With Intraoperative Cavity Margin Assessment: A Single Center,Randomized,Controlled Trial
- ClinicalTrials.gov ID
- NCT02648802
- Acronym / sponsor ID
- CSBCS1
- Conditions
- Breast Cancer
- Keywords
- breast-conserving surgery(BCS), Cavity shave margin, Proportion of positive margins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 7 Jan 2016 (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 randomized controlled trial is to evaluate the impact of additional cavity shaving (CS) on pathological cavity margin (CM) status in breast cancer patients. Patients receiving standard breast-conserving surgery (BCS) will be randomized to intra-operative CM assessment versus intra-operative CS followed by CM assessment. The primary objective of this study is to assess the impact of CS on intra-operative CM status, intra-operative re-excision rate, post-operative CM status and re-excision rate, cosmetic outcomes, and on intraoperative time and medical costs.
Detailed description
After stratified and blocked randomization, the patients' name, admission ID and treatment assignment will be written on a slip of paper, and will be placed in a sealed envelop. A label with the patients' name and admission ID will be placed on the sealed envelop, which will be kept in a locked file. On the day of surgery, a research coordinator will bring the sealed envelope to the operation room. During the standard-of-care BCS, the tumor was excised with a rim of grossly normal tissue. Additional resections are allowed when any of the margins of the tumor-containing specimen were suspected to be inadequate on the basis of standard gross evaluation by surgeons. Prior to intra-operative CM assessment, the research co-ordinator will unseal the envelop and determine which procedure has been designated to the patient. The cosmetic outcome and the quality of life will be evaluated at the day of discharge, after completion of radiotherapy and one year by the patient herself, her partner and a research co-ordinator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cavity shaving and CM assessment | Experimental | Procedure: Cavity shaving, Procedure: Standardized BCS+CM assessment.Standardized BCS with additional cavity shaving before CM assessment. |
| CM assessment | Placebo comparator | Procedure: Standardized BCS+CM assessment.Standardized BCS with CM assessment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- At least 18 years of age and no more than 65 years of age
- Able to understand and willing to sign an informed consent document
- Willing and planning to undergo the breast-conserving surgery
- ECOG≤ 2
Key exclusion criteria (16 listed)
- Inflammatory breast cancer
- Preference for mastectomy instead of breast-conserving surgery
- Necessity to undergo oncoplastic breast surgery
- Prior surgical treatment, including ultrasound-guided vacuum-assisted biopsy and excision biopsy.
- Prior systemic therapy for this diagnosis, including neoadjuvant chemotherapy, neoadjuvant endocrine therapy.
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 |
|---|---|---|
| Cavity shavingResect the residual cavity circumferentially (superior, inferior, medial, lateral) and the thickness of the cavity shaving depends on the surgeon's discretion (Recommended 0.5-1.0cm). The principles of the cavity shaving includes: 1) do not compromise the cosmetic outcomes; 2) covers the entire cavity; | Procedure or surgery | Cavity shaving and CM assessment |
| Standardized BCS+CM assessment.For standardized BCS(Chen K, et al. Ann Surg Oncol. 2012), we resect a rim of 1 cm macroscopically normal tissue around the tumor. The anterior and posterior margins of the tumor-containing specimen extended up to the subdermal plane of the skin and down to the pectoralis major fascia, respectively. The anterior and posterior CMs assessment will not be needed. A surgical blade was used for resecting the CMs (superior, inferior, medial and lateral) to render the thickness of the CMs as thin as possible. No procedures were required for distinguishing the inner and outer surface. They were then frozen and cut parallel, but not perpendicular to the largest surface area. CMs were defined as positive when in situ or invasive carcinoma was found intraoperatively by frozen-section analysis. | Procedure or surgery | CM assessment, Cavity shaving and CM assessment |
Primary outcome
Positivity rate of CMs by intraoperative frozen section analysis.
Time frame: Completion of surgery for all enrolled patients (approximately 12 months)
Proportion of patients with at least one positive(invasive carcinoma or carcinoma in situ, excluding LCIS) CMs on intraoperative frozen section analysis
9 secondary outcomes
Intra-operative rate of suspected/positive CM
Time frame: Completion of surgery for all enrolled patients (approximately 12 months)
Rate of intra-operative re-excision for suspected/positive CMs
Time frame: Completion of surgery for all enrolled patients (approximately 12 months)
Rate of a second-time surgery for post-operative positive CMs
Time frame: Completion of surgery for all enrolled patients (approximately 12 months)
Proportion of patients successfully undergone BCT
Time frame: Completion of surgery for all enrolled patients (approximately 12 months)
Cost-effectiveness of cavity shaving in BCS as measured by operative time of the surgery
Time frame: Completion of surgery for all enrolled patients (approximately 12 months)
Cost-effectiveness of cavity shaving in BCS as measured by medical cost of the surgery
Time frame: Completion of surgery for all enrolled patients (approximately 12 months)
Cosmetic outcome
Time frame: One year after surgery.
Adverse events
Time frame: One year after surgery.
Quality of life.
Time frame: One year after surgery.
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 22 Aug 2019.
- 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 24521674Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chavez-MacGregor M, Freedman G, Houssami N, Johnson PL, Morrow M. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. Int J Radiat Oncol Biol Phys. 2014 Mar 1;88(3):553-64. doi: 10.1016/j.ijrobp.2013.11.012.
- Background: PubMed 19826024Morrow M, Jagsi R, Alderman AK, Griggs JJ, Hawley ST, Hamilton AS, Graff JJ, Katz SJ. Surgeon recommendations and receipt of mastectomy for treatment of breast cancer. JAMA. 2009 Oct 14;302(14):1551-6. doi: 10.1001/jama.2009.1450.
- Background: PubMed 16038815Cendan JC, Coco D, Copeland EM 3rd. Accuracy of intraoperative frozen-section analysis of breast cancer lumpectomy-bed margins. J Am Coll Surg. 2005 Aug;201(2):194-8. doi: 10.1016/j.jamcollsurg.2005.03.014.
- Background: PubMed 26028131Chagpar AB, Killelea BK, Tsangaris TN, Butler M, Stavris K, Li F, Yao X, Bossuyt V, Harigopal M, Lannin DR, Pusztai L, Horowitz NR. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015 Aug 6;373(6):503-10. doi: 10.1056/NEJMoa1504473. Epub 2015 May 30.
- Background: PubMed 21494401Kayar R, Civelek S, Cobanoglu M, Gungor O, Catal H, Emiroglu M. Five methods of breast volume measurement: a comparative study of measurements of specimen volume in 30 mastectomy cases. Breast Cancer (Auckl). 2011 Mar 27;5:43-52. doi: 10.4137/BCBCR.S6128.
- Background: PubMed 22488098Chen K, Zeng Y, Jia H, Jia W, Yang H, Rao N, Song E, Cox CE, Su F. Clinical outcomes of breast-conserving surgery in patients using a modified method for cavity margin assessment. Ann Surg Oncol. 2012 Oct;19(11):3386-94. doi: 10.1245/s10434-012-2331-5. Epub 2012 Apr 10.
- Derived from this study: PubMed 31429019Chen K, Zhu L, Chen L, Li Q, Li S, Qiu N, Yang Y, Su F, Song E. Circumferential Shaving of the Cavity in Breast-Conserving Surgery: A Randomized Controlled Trial. Ann Surg Oncol. 2019 Dec;26(13):4256-4263. doi: 10.1245/s10434-019-07725-w. Epub 2019 Aug 19.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data will be available after the research paper has been published.
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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.
Fengxi Su, M.D. principal investigator
Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cavity shaving and Standardized BCS+CM assessment. in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of 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 5 inclusion and 16 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 22 Aug 2019. 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. Some participants in this study may receive a placebo. 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?
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?
Positivity rate of CMs by intraoperative frozen section analysis. (time frame: Completion of surgery for all enrolled patients (approximately 12 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 NCT02648802, which also lists 9 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 22 Aug 2019.