Bladder CancerNCT02145390
Chemoradiation for Bladder Preservation After Complete Response to Neoadjuvant Chemotherapy
A study testing Transurethral Resection of the Bladder Tumor & Cystoscopy, Intensity Modulated Radiation Therapy and Expanded Prostate Cancer Index Composite Short Form 12 in people with Bladder Cancer and Bladder Carcinoma, run by University of Miami at 1 site in United States.
Trial summary
Bladder preservation in patients with complete response after neoadjuvant chemotherapy will lead to equivalent or superior relapse free rates compared to cystectomy rates from historical controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Bladder Carcinoma, Transition Cell Cancer
- What is being tested?
- Transurethral Resection of the Bladder Tumor & Cystoscopy, Intensity Modulated Radiation Therapy and Expanded Prostate Cancer Index Composite Short Form 12
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2016to 25 Apr 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven diagnosis of primary carcinoma of the bladder(transitional cell cancer). Must be operable patients with muscularis propria invasion and American Joint Committee on Cancer (AJCC) clinical stages T2-4a, N0 or N+, M0. Patients with prostatic urethra involvement with transitional cell cancer (TCC) are eligible if it is completely resected and the patient has no evidence of stromal invasion of the prostate.
- Patients must be able to tolerate systemic chemotherapy combined with pelvic radiation therapy and radical cystectomy.
- Zubrod Performance Status of ≤1.
- Age ≥18.
- Complete Blood Count (CBC)/differential obtained no more than 8 weeks prior to enrollment on study, with adequate bone marrow function defined as follows:
- White Blood Cell (WBC) ≥ 4000/ml
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- Absolute neutrophil count (ANC) ≥1,800 cells/mm
- Platelets ≥100,000 cells/mm
- Hemoglobin ≥ 10.0 mg/dl (Note: the use of transfusion or other intervention to achieve this level is acceptable)
- Serum bilirubin of 2.0mg or less;
- Serum creatinine of 1.5mg or less; creatinine clearance of 60ml/min or greater no more than 8 weeks prior to enrollment (Note: calculated creatinine clearance is permissible, using Cockcroft-Gault formula. If the creatinine clearance is greater than 60ml/min, then a serum creatinine of up to 1.8mg is allowable at the discretion of the principal investigator.)
- Note: Prechemotherapy laboratory investigations and Eastern Cooperative Oncology Group (ECOG) evaluation must meet inclusion criteria irrespective of where they were drawn, retroactive, prior to cycle 1 of cisplatin/gemcitabine. Inclusion criteria from these initial investigations will be used for evaluation of enrollment eligibility.
- Patients must be willing and able to provide study-specific informed consent prior to study entry
Who cannot join
- Tumor related untreated active hydronephrosis
- Evidence of distant metastases.
- Diffuse bladder carcinoma in situ (CIS) not able to be encompassed in a boost radiotherapy volume.
- Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy
- A prior or concurrent malignancy of any other site or histology unless the patient has been disease free for greater than or equal to five years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix
- Patients that are not candidates for radical cystectomy (T4b disease are considered unresectable)
Show all 15Show fewer
- Pregnancy or women of childbearing potential [not post-menopausal or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy)] and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
- Severe active co-morbidity:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of enrollment
- History of hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (Note: laboratory tests for liver function and coagulation parameters are not required for enrollment into this protocol)
- Known diagnosis of Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition (Note: HIV testing is not required for enrollment into this protocol). The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- As determined by the investigator or principal investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
Official title: A Phase II Study of Chemoradiation for Bladder Preservation in Patients With Muscle Invasive Bladder Carcinoma After Complete Response to Neoadjuvant Chemotherapy
Bladder preservation in patients with complete response after neoadjuvant chemotherapy will lead to equivalent or superior relapse free rates compared to cystectomy rates from historical controls.
Read the detailed description
- Transurethral Resection of the Bladder Tumor (TURBT) and Cystoscopy performed by participating urologist:
- cystoscopic evaluation
- bimanual examination under anesthesia,
- as thorough as possible a transurethral resection (TUR) of the bladder tumor,
- and a biopsy of the prostatic urethra including both mucosa and stroma using a resection loop.
- Neoadjuvant Chemotherapy, per standard of care: All patients will receive the neoadjuvant course of chemotherapy. The recommended neoadjuvant chemotherapy regimen consists of Gemcitabine and Cisplatin given on a 21-day cycle.This regimen will begin within 8 weeks following the TURBT and cystoscopic evaluation by the urologic surgeon;
- Post-Neoadjuvant Evaluation: This evaluation will take place ≤ 6 weeks following the completion of the neoadjuvant chemotherapy. Evaluation will include:
- urine cytology,
- cystoscopy,
- tumor site transurethral biopsy,
- and bimanual examination after biopsy
- and biopsy of TURBT site
- For subjects with complete response to neoadjuvant chemotherapy: Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT), and concurrent Cisplatin therapy, per standard of care; OR
- For subjects with pT1 or worse tumor response to neoadjuvant chemotherapy: Radical Cystectomy within 12 weeks after post-neoadjuvant evaluation;
- Post-Consolidation Endoscopic Evaluations: The first post-treatment evaluation will be 30 days +/- 14 days within the end of chemoradiation, surgery or at progression. Subsequent cystoscopic evaluation will be every three months in the first year, every four months in the second year, and every six months in the third year (all evaluations to occur +/- 14 days). Each evaluation will include serum, plasma, whole blood, urine cytology.
- Conditions
- Bladder Cancer, Bladder Carcinoma, Transition Cell Cancer, Muscle Invasive Bladder Carcinoma
- Being tested
- Transurethral Resection of the Bladder Tumor & Cystoscopy, Intensity Modulated Radiation Therapy, Expanded Prostate Cancer Index Composite Short Form 12, International Prostate Symptom Score
- Keywords
- Bladder Cancer, Bladder Carcinoma, Transition Cell Cancer, TCC, Muscle Invasive Bladder Carcinoma
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral Resection of the Bladder Tumor & CystoscopyProcedure or surgery
Also called TURBT
TURBT and Cystoscopy will be performed by the participating urologist prior to start of neoadjuvant chemotherapy, per the study protocol:
- Cystoscopic evaluation
- Bimanual examination under anesthesia,
- Transurethral resection of the bladder tumor,
- Biopsy of the prostatic urethra including both mucosa and stroma using a resection loop.
Intensity Modulated Radiation TherapyRadiation
Also called IMRT, VMAT
For subjects with complete response to neoadjuvant chemotherapy. Subjects will receive 25 daily fractions (5 weeks) of radiation therapy for 5 days a week (Monday to Friday) except on weekends or holidays, when remaining fractions will be added to the end of treatment. The overall schema is for IMRT based radiation to the entire bladder, prostate (in men) and the pelvic lymph nodes:
- Pelvic lymph nodes: 45 Gy in 25 fractions at 1.8 Gy per fraction.
- Whole bladder and prostate: 50 Gy in 25 fractions at 2.0 Gy per fraction.
- Tumor boost area: 60-65 Gy in 25 fractions at 2.4-2.6 Gy per day
- Final boost dose will be determined at the discretion of the treating physician based on normal tissue exposure and volume.
Expanded Prostate Cancer Index Composite Short Form 12Behavioural
Also called EPIC SF-12
Quality of life questionnaire to be administered to subjects at intervals defined by the study protocol.
International Prostate Symptom ScoreBehavioural
Also called IPSS
Quality of life questionnaire to be administered to subjects at intervals defined by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| TURBT, NAC and Chemoradiation | Experimental | * Transurethral Resection of the Bladder Tumor \& Cystoscopy (TURBT);
* Neoadjuvant Chemotherapy (NAC), per standard of care: Cisplatin and Gemcitabine therapy, within 8 weeks following the TURBT and cystoscopic evaluation;
* For subjects with complete response (CR): Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT); Cisplatin therapy per standard of care;
* For subjects who have pT1 or worse tumor response: Radical Cystectomy, per standard of care, within 12 weeks post-neoadjuvant chemotherapy evaluation;
* Expanded Prostate Cancer Index Composite Short Form 12 (EPIC SF-12);
* International Prostate Symptom Score (IPSS). Receives: Procedure: Transurethral Resection of the Bladder Tumor & Cystoscopy; Radiation: Intensity Modulated Radiation Therapy; Behavioral: Expanded Prostate Cancer Index Composite Short Form 12; Behavioral: International Prostate Symptom Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Failure-Free Survival With Intact Bladder (FFSIB) in Study Participants
Rate of failure free survival with intact bladder (FFSIB) at two years in subjects undergoing bladder preservation. FFSIB is defined by the absence of any failures (locoregional, distant metastasis, and death) and bladder preservation (no radical cystectomy for any causes) after definitive chemoradiation. FFSIB is defined as the time elapsed from the start of neoadjuvant chemotherapy to the date of documented failure events or radical cystectomy. For failure-free patients (without failure events and no radical cystectomy), FFSIB will be censored at the last date of documented failure-free bladder preservation (FFBP) status.
Measured: 2 years
Secondary outcomes (3)
Rate of Failure-Free Survival (FFS) at Two Years
The two year rate of failure free survival (FFS) in study participants. This will include locoregional recurrence, and distant metastases. FFS is defined as absence of any failures (locoregional, distant metastasis, and death) during the time elapsed from the start of neoadjuvant chemotherapy to the date of documented failure events or radical cystectomy.
Measured: 2 Years
Rate of Acute and Late Grade 2 or Higher Treatment-Related GU, GI and Hematologic Toxicity.
The rate of acute and late grade 2 or higher (CTCAE v4.0) treatment-related genitourinary (GU), gastrointestinal (GI) and hematologic toxicity of bladder preservation in study participants.
Measured: Up to 2 years Post-Treatment
Rate of Overall Survival in Study Participants
Rate of Overall Survival in Study Participants. Overall survival (OS) is defined as the time elapsed from the start of neoadjuvant chemotherapy until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study start5 Jan 2016
- Primary completion25 Apr 2017
- Study completion25 Apr 2017
Why it stopped: Investigator Decision - Insufficient Accrual
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.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Ishkanian, University of Miami
- Investigators
- Adrian S Ishkanian, MD, Principal investigator, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145390
- Sponsor's protocol ID
- 20130896
- Status last verified
- Aug 2018
- First submitted
- 20 May 2014
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Chemoradiation for Bladder Preservation in Patients With Muscle Invasive Bladder Carcinoma After Complete Response to Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02145390
- Acronym / sponsor ID
- 20130896
- Conditions
- Bladder Cancer, Bladder Carcinoma, Transition Cell Cancer, Muscle Invasive Bladder Carcinoma
- Keywords
- Bladder Cancer, Bladder Carcinoma, Transition Cell Cancer, TCC, Muscle Invasive Bladder Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator Decision - Insufficient Accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Posted 28 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bladder preservation in patients with complete response after neoadjuvant chemotherapy will lead to equivalent or superior relapse free rates compared to cystectomy rates from historical controls.
Detailed description
- Transurethral Resection of the Bladder Tumor (TURBT) and Cystoscopy performed by participating urologist:
- cystoscopic evaluation
- bimanual examination under anesthesia,
- as thorough as possible a transurethral resection (TUR) of the bladder tumor,
- and a biopsy of the prostatic urethra including both mucosa and stroma using a resection loop.
- Neoadjuvant Chemotherapy, per standard of care: All patients will receive the neoadjuvant course of chemotherapy. The recommended neoadjuvant chemotherapy regimen consists of Gemcitabine and Cisplatin given on a 21-day cycle.This regimen will begin within 8 weeks following the TURBT and cystoscopic evaluation by the urologic surgeon;
- Post-Neoadjuvant Evaluation: This evaluation will take place ≤ 6 weeks following the completion of the neoadjuvant chemotherapy. Evaluation will include:
- urine cytology,
- cystoscopy,
- tumor site transurethral biopsy,
- and bimanual examination after biopsy
- and biopsy of TURBT site
- For subjects with complete response to neoadjuvant chemotherapy: Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT), and concurrent Cisplatin therapy, per standard of care; OR
- For subjects with pT1 or worse tumor response to neoadjuvant chemotherapy: Radical Cystectomy within 12 weeks after post-neoadjuvant evaluation;
- Post-Consolidation Endoscopic Evaluations: The first post-treatment evaluation will be 30 days +/- 14 days within the end of chemoradiation, surgery or at progression. Subsequent cystoscopic evaluation will be every three months in the first year, every four months in the second year, and every six months in the third year (all evaluations to occur +/- 14 days). Each evaluation will include serum, plasma, whole blood, urine cytology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TURBT, NAC and Chemoradiation | Experimental | Procedure: Transurethral Resection of the Bladder Tumor & Cystoscopy, Radiation: Intensity Modulated Radiation Therapy, Behavioral: Expanded Prostate Cancer Index Composite Short Form 12, Behavioral: International Prostate Symptom Score* Transurethral Resection of the Bladder Tumor \& Cystoscopy (TURBT); * Neoadjuvant Chemotherapy (NAC), per standard of care: Cisplatin and Gemcitabine therapy, within 8 weeks following the TURBT and cystoscopic evaluation; * For subjects with complete response (CR): Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT); Cisplatin therapy per standard of care; * For subjects who have pT1 or worse tumor response: Radical Cystectomy, per standard of care, within 12 weeks post-neoadjuvant chemotherapy evaluation; * Expanded Prostate Cancer Index Composite Short Form 12 (EPIC SF-12); * International Prostate Symptom Score (IPSS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pathologically proven diagnosis of primary carcinoma of the bladder(transitional cell cancer). Must be operable patients with muscularis propria invasion and American Joint Committee on Cancer (AJCC) clinical stages T2-4a, N0 or N+, M0. Patients with prostatic urethra involvement with transitional cell cancer (TCC) are eligible if it is completely resected and the patient has no evidence of stromal invasion of the prostate.
- Patients must be able to tolerate systemic chemotherapy combined with pelvic radiation therapy and radical cystectomy.
- Zubrod Performance Status of ≤1.
- Age ≥18.
- Complete Blood Count (CBC)/differential obtained no more than 8 weeks prior to enrollment on study, with adequate bone marrow function defined as follows:
Key exclusion criteria (15 listed)
- Tumor related untreated active hydronephrosis
- Evidence of distant metastases.
- Diffuse bladder carcinoma in situ (CIS) not able to be encompassed in a boost radiotherapy volume.
- Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy
- A prior or concurrent malignancy of any other site or histology unless the patient has been disease free for greater than or equal to five years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix
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 |
|---|---|---|
| Transurethral Resection of the Bladder Tumor & CystoscopyAlso: TURBTTURBT and Cystoscopy will be performed by the participating urologist prior to start of neoadjuvant chemotherapy, per the study protocol: * Cystoscopic evaluation * Bimanual examination under anesthesia, * Transurethral resection of the bladder tumor, * Biopsy of the prostatic urethra including both mucosa and stroma using a resection loop. | Procedure or surgery | TURBT, NAC and Chemoradiation |
| Intensity Modulated Radiation TherapyAlso: IMRT, VMATFor subjects with complete response to neoadjuvant chemotherapy. Subjects will receive 25 daily fractions (5 weeks) of radiation therapy for 5 days a week (Monday to Friday) except on weekends or holidays, when remaining fractions will be added to the end of treatment. The overall schema is for IMRT based radiation to the entire bladder, prostate (in men) and the pelvic lymph nodes: * Pelvic lymph nodes: 45 Gy in 25 fractions at 1.8 Gy per fraction. * Whole bladder and prostate: 50 Gy in 25 fractions at 2.0 Gy per fraction. * Tumor boost area: 60-65 Gy in 25 fractions at 2.4-2.6 Gy per day * Final boost dose will be determined at the discretion of the treating physician based on normal tissue exposure and volume. | Radiation | TURBT, NAC and Chemoradiation |
| Expanded Prostate Cancer Index Composite Short Form 12Also: EPIC SF-12Quality of life questionnaire to be administered to subjects at intervals defined by the study protocol. | Behavioural | TURBT, NAC and Chemoradiation |
| International Prostate Symptom ScoreAlso: IPSSQuality of life questionnaire to be administered to subjects at intervals defined by the study protocol. | Behavioural | TURBT, NAC and Chemoradiation |
Primary outcome
Rate of Failure-Free Survival With Intact Bladder (FFSIB) in Study Participants
Time frame: 2 years
Rate of failure free survival with intact bladder (FFSIB) at two years in subjects undergoing bladder preservation. FFSIB is defined by the absence of any failures (locoregional, distant metastasis, and death) and bladder preservation (no radical cystectomy for any causes) after definitive chemoradiation. FFSIB is defined as the time elapsed from the start of neoadjuvant chemotherapy to the date of documented failure events or radical cystectomy. For failure-free patients (without failure events and no radical cystectomy), FFSIB will be censored at the last date of documented failure-free bladder preservation (FFBP) status.
3 secondary outcomes
Rate of Failure-Free Survival (FFS) at Two Years
Time frame: 2 Years
Rate of Acute and Late Grade 2 or Higher Treatment-Related GU, GI and Hematologic Toxicity.
Time frame: Up to 2 years Post-Treatment
Rate of Overall Survival in Study Participants
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Adrian S Ishkanian, MD principal investigator
University of Miami Sylvester Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transurethral Resection of the Bladder Tumor & Cystoscopy, Intensity Modulated Radiation Therapy and Expanded Prostate Cancer Index Composite Short Form 12 in people with Bladder Cancer and Bladder Carcinoma, run by University of Miami at 1 site in United States.
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 13 inclusion and 15 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: stopped early, as of the sponsor's last update on 28 Aug 2018. 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 United States. 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 28 Aug 2018). 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?
Rate of Failure-Free Survival With Intact Bladder (FFSIB) in Study Participants (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2018.