Rectal CancerTiMiSNARNCT03465982
Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer
A study testing Surgery after 8 weeks from chemoradiation treatment and Surgery after 12 weeks from chemoradiation treatment in people with Rectal Cancer, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 14 sites in Italy.
Trial summary
The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Surgery after 8 weeks from chemoradiation treatment and Surgery after 12 weeks from chemoradiation treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 14 sitesItaly
- Study dates
- 5 Jun 2018to 5 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age >18 years
- cT3/4N0/+M0 confirmed on CT-scan, MRI (stratification for T3a-b-c-d) 3
- Tumor starting from the distal or medium rectum (even those crossing the peritoneal reflection at distal margin, within 15 cm from the anal margin)
- Histologically-proven adenocarcinoma of the rectum
- Eligible for a resective surgery with TME (low anterior resection, intersphincteric resection, abdominoperineal resection)
- Eligible for resection by minimally-invasive surgery (standard or robotic-assisted laparoscopic procedure, all robotic systems will be accepted)
Show all 9Show fewer
- Eligible for chemoradiation treatment
- Able to give written informed consent
- Capable of completing required questionnaires at time of consent (provided questionnaires are available in a language spoke fluently by the participant)
Who cannot join
- Metastatic disease
- Squamous carcinoma of the anal canal
- Synchronous colorectal tumors requiring multi-segment surgical resection (n.b. a benign lesion within the resection field in addition to the main cancer would not exclude a patient)
- History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
- Pregnancy
- Unable to complete neoadjuvant treatment
Show all 12Show fewer
- Unable to give free informed consent
- Previous radiation treatment on the pelvis
- Inflammatory bowel disease
- Hereditary colorectal disease
- Previous tumors other than non-melanoma skin cancer, papillary or follicular thyroid cancer
- Participation in another rectal cancer clinical trial relating to the topic of this trial
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Italy14 sites, 11 recruiting
- Suspended
Ente Ecclesiastico ospedale generale Regionale Miulli
Acquaviva delle Fonti
- Recruiting
SS. Antonio e Biagio e Cesare Arrigo Hospital
Alessandria, AL, 15121
Igor Monsellato, Md, PhD
Igor Monsellato, MD, PhD
- Recruiting
Ospedale degli Infermi
Biella
Roberto Perinotti, MD
Roberto Perinotti, MD
- Recruiting
Istituto del Radio Olindo Alberti, Spedali Civili di Brescia
Brescia
Marco LF Bonù, MD, marco.bonu@unibs.it
Vittorio Morelli, MD
- Recruiting
Ospedale Civile Pietro Cosma
Camposampiero, Padua
Enzo Mammano, MD
Emilio Morpurgo, MD
- Recruiting
ASST Ospedale di Cremona
Cremona
Gianluca Baiocchi, Prof, gianluca.baiocchi@unibs.it
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence
Federico Perna, MD
Federico Perna, MD
- Recruiting
Ospedale Gian Battista Morgagni - Luigi Pierantoni
Forlì, Forlì-Cesena
Davide Cavaliere, MD
Davide Cavaliere, MD
- Recruiting
Ospedale Maggiore Policlinico Fondazione Ca' Granda
Milan
Luigi Boni, FACS
Luigi Boni, FACS
- Recruiting
Ospedale San Raffaele IRCCS
Milan
Ugo Elmore
Ugo Elmore
- Recruiting
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
Naples
Paolo Delrio, Prof
Paolo Delrio, Prof
- Recruiting
Ospedale Sacro Cuore
Negrar, Verona
Giacomo Ruffo
Giacomo Ruffo, MD
- Terminated
Ospedale San Francesco
Nuoro
- Suspended
Azienda Ospedaliera San Giovanni - Addolorata
Roma
About this study
Official title: Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial
The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. The recruiting interval will be of 5 years and the follow-up period will end 5 years after the last patient is randomized.
Read the detailed description
PURPOSE
To demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathological complete response (pCR) and reflects on disease-free survival (DFS) and overall survival (OS) rather than standard timing. Eight weeks are the current standard interval to surgery after neoadjuvant treatment, while 12 weeks represent the "minimum" longer time interval to determine further tumor modifications and the "a priori" choice to avoid hypothetical surgical detrimental effect (postoperative complications related to radiation therapy).
Primary Endpoint
- pCR
Secondary Endpoints
- DFS
- OS
- QoL (quality of Life)
Site Eligibility
The trial is a multicenter collaboration, involving all those centers able to provide the standard of cure for locally advanced rectal cancer. All the involved centers have to respect the following criteria:
- Site able to perform robotic-assisted and standard laparoscopic rectal cancer surgery and TaTME (transanal total mesorectal excision)
- Site able to provide a preoperative work up according to the work up criteria specified in this trial
- Site able to provide standard neoadjuvant treatment, both chemo and radiation therapy, according to the criteria specified in this trial
- Predicted capability to recruit a minimum of 15 patients per year to the trial.
Randomization will take place after consent is obtained and after patients have completed their baseline patient reported questionnaires. Patient consent and randomization will take place as close to the date of start of the neoadjuvant treatment as possible and must be no more than 30 days prior to planned treatment.
- Conditions
- Rectal Cancer
- Being tested
- Surgery after 8 weeks from chemoradiation treatment, Surgery after 12 weeks from chemoradiation treatment
- Keywords
- rectal cancer, robotic rectal cancer resection, minimally invasive surgery, Colorectal Cancer, chemoradiation treatment rectal cancer
- Medical subject headings
- Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery after 8 weeks from chemoradiation treatmentProcedure or surgery
Minimally invasive surgery after 8 weeks from chemoradiation treatment
Surgery after 12 weeks from chemoradiation treatmentProcedure or surgery
Minimally invasive surgery after 12 weeks from chemoradiation treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard Interval Time Arm | Active comparator | Minimally invasive surgery after 8 weeks from chemoradiation treatment Receives: Procedure: Surgery after 8 weeks from chemoradiation treatment |
| Delayed Interval Time Arm | Active comparator | Minimally invasive surgery after 12 weeks from chemoradiation treatment Receives: Procedure: Surgery after 12 weeks from chemoradiation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response (pCR)
Pathologic Complete response on cancer defined as absence of cancer cells on specimen
Measured: 8-12 weeks
Secondary outcomes (2)
DFS
Disease Free survival
Measured: 5 years
OS
Overall Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start5 Jun 2018
- Primary completion5 Jun 2025 (estimated)
- Study completion5 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Monsellato, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465982
- Sponsor's protocol ID
- 1/18
- Acronym
- TiMiSNAR
- Status last verified
- Apr 2024
- First submitted
- 23 Feb 2018
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.
PubMed 15496622Petrelli F, Sgroi G, Sarti E, Barni S. Increasing the Interval Between Neoadjuvant Chemoradiotherapy and Surgery in Rectal Cancer: A Meta-analysis of Published Studies. Ann Surg. 2016 Mar;263(3):458-64. doi: 10.1097/SLA.0000000000000368.
PubMed 24263329Erlandsson J, Holm T, Pettersson D, Berglund A, Cedermark B, Radu C, Johansson H, Machado M, Hjern F, Hallbook O, Syk I, Glimelius B, Martling A. Optimal fractionation of preoperative radiotherapy and timing to surgery for rectal cancer (Stockholm III): a multicentre, randomised, non-blinded, phase 3, non-inferiority trial. Lancet Oncol. 2017 Mar;18(3):336-346. doi: 10.1016/S1470-2045(17)30086-4. Epub 2017 Feb 10.
PubMed 28190762Kaytan-Saglam E, Balik E, Saglam S, Akgun Z, Ibis K, Keskin M, Dagoglu N, Kapran Y, Gulluoglu M. Delayed versus immediate surgery following short-course neoadjuvant radiotherapy in resectable (T3N0/N+) rectal cancer. J Cancer Res Clin Oncol. 2017 Aug;143(8):1597-1603. doi: 10.1007/s00432-017-2406-6. Epub 2017 Apr 3.
PubMed 28374169Lefevre JH, Mineur L, Kotti S, Rullier E, Rouanet P, de Chaisemartin C, Meunier B, Mehrdad J, Cotte E, Desrame J, Karoui M, Benoist S, Kirzin S, Berger A, Panis Y, Piessen G, Saudemont A, Prudhomme M, Peschaud F, Dubois A, Loriau J, Tuech JJ, Meurette G, Lupinacci R, Goasgen N, Parc Y, Simon T, Tiret E. Effect of Interval (7 or 11 weeks) Between Neoadjuvant Radiochemotherapy and Surgery on Complete Pathologic Response in Rectal Cancer: A Multicenter, Randomized, Controlled Trial (GRECCAR-6). J Clin Oncol. 2016 Nov 1;34(31):3773-3780. doi: 10.1200/JCO.2016.67.6049.
PubMed 27432930Monsellato I, Alongi F, Bertocchi E, Gori S, Ruffo G, Cassinotti E, Baldari L, Boni L, Pernazza G, Pulighe F, De Nisco C, Perinotti R, Morpurgo E, Contardo T, Mammano E, Elmore U, Delpini R, Rosati R, Perna F, Coratti A, Menegatti B, Gentilli S, Baroffio P, Buccianti P, Balestri R, Ceccarelli C, Torri V, Cavaliere D, Solaini L, Ercolani G, Traverso E, Fusco V, Rossi M, Priora F, Numico G, Franzone P, Orecchia S. Standard (8 weeks) vs long (12 weeks) timing to minimally-invasive surgery after NeoAdjuvant Chemoradiotherapy for rectal cancer: a multicenter randomized controlled parallel group trial (TiMiSNAR). BMC Cancer. 2019 Dec 16;19(1):1215. doi: 10.1186/s12885-019-6271-3.
PubMed 31842784
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing to Minimally Invasive Surgery After Neoadjuvant Chemoradiotherapy for Rectal Cancer: a Multicenter Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03465982
- Acronym / sponsor ID
- TiMiSNAR / 1/18
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, robotic rectal cancer resection, minimally invasive surgery, Colorectal Cancer, chemoradiation treatment rectal cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 5 Jun 2025 (estimated)
- Study completion
- 5 Jun 2029 (estimated)
- First posted
- 15 Mar 2018 (actual)
- 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.
The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and thirty-two patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. The recruiting interval will be of 5 years and the follow-up period will end 5 years after the last patient is randomized.
Detailed description
PURPOSE
To demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathological complete response (pCR) and reflects on disease-free survival (DFS) and overall survival (OS) rather than standard timing. Eight weeks are the current standard interval to surgery after neoadjuvant treatment, while 12 weeks represent the "minimum" longer time interval to determine further tumor modifications and the "a priori" choice to avoid hypothetical surgical detrimental effect (postoperative complications related to radiation therapy).
Primary Endpoint
- pCR
Secondary Endpoints
- DFS
- OS
- QoL (quality of Life)
Site Eligibility
The trial is a multicenter collaboration, involving all those centers able to provide the standard of cure for locally advanced rectal cancer. All the involved centers have to respect the following criteria:
- Site able to perform robotic-assisted and standard laparoscopic rectal cancer surgery and TaTME (transanal total mesorectal excision)
- Site able to provide a preoperative work up according to the work up criteria specified in this trial
- Site able to provide standard neoadjuvant treatment, both chemo and radiation therapy, according to the criteria specified in this trial
- Predicted capability to recruit a minimum of 15 patients per year to the trial.
Randomization will take place after consent is obtained and after patients have completed their baseline patient reported questionnaires. Patient consent and randomization will take place as close to the date of start of the neoadjuvant treatment as possible and must be no more than 30 days prior to planned treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Interval Time Arm | Active comparator | Procedure: Surgery after 8 weeks from chemoradiation treatmentMinimally invasive surgery after 8 weeks from chemoradiation treatment |
| Delayed Interval Time Arm | Active comparator | Procedure: Surgery after 12 weeks from chemoradiation treatmentMinimally invasive surgery after 12 weeks from chemoradiation treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >18 years
- cT3/4N0/+M0 confirmed on CT-scan, MRI (stratification for T3a-b-c-d) 3
- Tumor starting from the distal or medium rectum (even those crossing the peritoneal reflection at distal margin, within 15 cm from the anal margin)
- Histologically-proven adenocarcinoma of the rectum
- Eligible for a resective surgery with TME (low anterior resection, intersphincteric resection, abdominoperineal resection)
Key exclusion criteria (12 listed)
- Metastatic disease
- Squamous carcinoma of the anal canal
- Synchronous colorectal tumors requiring multi-segment surgical resection (n.b. a benign lesion within the resection field in addition to the main cancer would not exclude a patient)
- History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
- Pregnancy
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 |
|---|---|---|
| Surgery after 8 weeks from chemoradiation treatmentMinimally invasive surgery after 8 weeks from chemoradiation treatment | Procedure or surgery | Standard Interval Time Arm |
| Surgery after 12 weeks from chemoradiation treatmentMinimally invasive surgery after 12 weeks from chemoradiation treatment | Procedure or surgery | Delayed Interval Time Arm |
Primary outcome
pathologic complete response (pCR)
Time frame: 8-12 weeks
Pathologic Complete response on cancer defined as absence of cancer cells on specimen
2 secondary outcomes
DFS
Time frame: 5 years
OS
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Results publication: PubMed 15496622Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.
- Results publication: PubMed 24263329Petrelli F, Sgroi G, Sarti E, Barni S. Increasing the Interval Between Neoadjuvant Chemoradiotherapy and Surgery in Rectal Cancer: A Meta-analysis of Published Studies. Ann Surg. 2016 Mar;263(3):458-64. doi: 10.1097/SLA.0000000000000368.
- Results publication: PubMed 28190762Erlandsson J, Holm T, Pettersson D, Berglund A, Cedermark B, Radu C, Johansson H, Machado M, Hjern F, Hallbook O, Syk I, Glimelius B, Martling A. Optimal fractionation of preoperative radiotherapy and timing to surgery for rectal cancer (Stockholm III): a multicentre, randomised, non-blinded, phase 3, non-inferiority trial. Lancet Oncol. 2017 Mar;18(3):336-346. doi: 10.1016/S1470-2045(17)30086-4. Epub 2017 Feb 10.
- Results publication: PubMed 28374169Kaytan-Saglam E, Balik E, Saglam S, Akgun Z, Ibis K, Keskin M, Dagoglu N, Kapran Y, Gulluoglu M. Delayed versus immediate surgery following short-course neoadjuvant radiotherapy in resectable (T3N0/N+) rectal cancer. J Cancer Res Clin Oncol. 2017 Aug;143(8):1597-1603. doi: 10.1007/s00432-017-2406-6. Epub 2017 Apr 3.
- Results publication: PubMed 27432930Lefevre JH, Mineur L, Kotti S, Rullier E, Rouanet P, de Chaisemartin C, Meunier B, Mehrdad J, Cotte E, Desrame J, Karoui M, Benoist S, Kirzin S, Berger A, Panis Y, Piessen G, Saudemont A, Prudhomme M, Peschaud F, Dubois A, Loriau J, Tuech JJ, Meurette G, Lupinacci R, Goasgen N, Parc Y, Simon T, Tiret E. Effect of Interval (7 or 11 weeks) Between Neoadjuvant Radiochemotherapy and Surgery on Complete Pathologic Response in Rectal Cancer: A Multicenter, Randomized, Controlled Trial (GRECCAR-6). J Clin Oncol. 2016 Nov 1;34(31):3773-3780. doi: 10.1200/JCO.2016.67.6049.
- Derived from this study: PubMed 31842784Monsellato I, Alongi F, Bertocchi E, Gori S, Ruffo G, Cassinotti E, Baldari L, Boni L, Pernazza G, Pulighe F, De Nisco C, Perinotti R, Morpurgo E, Contardo T, Mammano E, Elmore U, Delpini R, Rosati R, Perna F, Coratti A, Menegatti B, Gentilli S, Baroffio P, Buccianti P, Balestri R, Ceccarelli C, Torri V, Cavaliere D, Solaini L, Ercolani G, Traverso E, Fusco V, Rossi M, Priora F, Numico G, Franzone P, Orecchia S. Standard (8 weeks) vs long (12 weeks) timing to minimally-invasive surgery after NeoAdjuvant Chemoradiotherapy for rectal cancer: a multicenter randomized controlled parallel group trial (TiMiSNAR). BMC Cancer. 2019 Dec 16;19(1):1215. doi: 10.1186/s12885-019-6271-3.
- Individual participant dataSharing planned: No
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery after 8 weeks from chemoradiation treatment and Surgery after 12 weeks from chemoradiation treatment in people with Rectal Cancer, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 14 sites in Italy.
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 9 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Igor Monsellato, MD (+390131206506, igor.monsellato@ospedale.al.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (pCR) (time frame: 8-12 weeks). 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 NCT03465982, which also lists 6 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 16 Apr 2024.