Gastric CancerNCT04915807
Real-world Data (RWD) of Ramucirumab Plus Paclitaxel
An observational study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Hallym University Medical Center at 9 sites in South Korea.
Trial summary
Real World Data (RWD) obtained from real clinical sites is data obtained after administering a drug to patients with different characteristics in daily practice, and Real World Evidence (RWE) is established based on RWD. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Ramucirumab and paclitaxel and Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy
- How many people
- 222 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Jun 2021to Sep 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting university hospitals located in major cities in South Korea
Who may be able to join
- Patients aged 19 years or older and histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
- Patients with locally advanced or metastatic disease for which curative resection is not possible.
- Patients who have failed fluoropyrimidine and platinum (cisplatin or oxaliplatin)-based chemotherapy as palliative first-line therapy
- Patients who is starting ramucirumab/paclitaxel combination therapy after the study initiation date
- Patients aged 19 years or older and histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
- Patients with locally advanced or metastatic disease for which curative resection is not possible
- Patients who have failed platinum-based palliative first-line therapy, and who started the following second-line therapy: taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy, before May 1, 2018
Who cannot join
- Patients receiving ramucirumab monotherapy
- Patients receiving ramucirumab/paclitaxel in clinical trial or receiving without being covered by health insurance
- Patients unable to communicate or incapable of understanding documents for patient report outcomes
- Historical retrospective population
- Patients receiving ramucirumab monotherapy
- Patients receiving ramucirumab/paclitaxel in clinical trial or receiving without being covered by health insurance
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Hallym University Sacred Heart Hospital
Anyang, 14068
Kyungpook National University Chilgok Hospital
Daegu, 41404
Keimyung University Dongsan Medical Center
Daegu, 42601
Seoul National University Bundang Hospital
Seongnam, 13620
Kyung Hee University Hospital
Seoul, 02447
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
About this study
Official title: A Prospective Study for Real-world Data (RWD) of Ramucirumab Plus Paclitaxel in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Real World Data (RWD) obtained from real clinical sites is data obtained after administering a drug to patients with different characteristics in daily practice, and Real World Evidence (RWE) is established based on RWD. It is possible to overcome the disadvantage of RCT, which cannot reflect all the various variables in the actual clinical field as it is conducted for only subset of patients.
Researchers planned to prospectively collect RWD of ramucirumab/paclitaxel combination therapy as 2nd-line chemotherapy in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Read the detailed description
Most drugs are introduced into the medical market based on efficacy derived from randomized controlled trials (RCTs) in a subset of patient groups in which the age, presence of comorbidities, and general conditions of the target patient are strictly controlled by the researcher.
Real World Data (RWD) obtained from real clinical sites is data obtained after administering a drug to patients with different characteristics in daily practice, and Real World Evidence (RWE) is established based on RWD. It is possible to overcome the disadvantage of RCT, which cannot reflect all the various variables in the actual clinical field as it is conducted for only subset of patients.
Researchers have collected retrospective RWD from patients who used ramucirumab/paclitaxel in a previous study (KCSG ST19-16). Considering the limitations of RWD obtained through retrospective data collection, it is necessary to generate RWE through RWD, which prospectively collects various clinical data obtained in the process of using new anticancer drugs.
- Being tested
- Ramucirumab and paclitaxel, Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy
- Keywords
- Real-world data, Gastric cancer, Gastroesophageal junction adenocarcinoma, Ramucirumab, Paclitaxel, Chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramucirumab and paclitaxelDrug
Also called Prospective population
Ramucirumab/paclitaxel as a second-line chemotherapy after May 1, 2018, when health insurance coverage for the combination therapy started
Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapyDrug
Also called Historical retrospective population
Taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy as a second-line therapy
| Study group | Role | What they receive |
|---|---|---|
| Prospective population | The target group for the purpose of prospectively collecting the clinical data (RWD) of patients using ramucirumab/paclitaxel as 2nd-line chemotherapy in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma Receives: Drug: Ramucirumab and paclitaxel | |
| Historical retrospective population | The target group for the purpose of retrospectively collecting the clinical data (RWD) of patients who have failed platinum-based palliative first-line therapy, and who started the following second-line therapy: taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy, before May 1, 2018, when health insurance coverage for the ramucirumab/paclitaxel combination therapy started in South Korea. Receives: Drug: Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from the start of ramucirumab/paclitaxel to death from any cause
Measured: Until September 30, 2023
Progression-free survival
Time from the start of ramucirumab/paclitaxel to disease progression or death from any cause
Measured: Until September 30, 2023
Secondary outcomes (6)
Incidence of adverse events
Number (percentage) of subjects reporting adverse events according to CTCAE v5.0
Measured: Until September 30, 2023
Time to progression
Time from the start of ramucirumab/paclitaxel to disease progression
Measured: Until September 30, 2023
Objective response rate
The proportion of subjects confirmed complete or partial response according to RECIST v1.1
Measured: Until September 30, 2023
Disease control rate
The proportion of subjects confirmed complete response, partial response or stable disease according to RECIST v1.1
Measured: Until September 30, 2023
Duration of response
Time from documentation of tumor response to disease progression
Measured: Until September 30, 2023
Adverse events of special interest
Number (percentage) of subjects reporting adverse events of special interest associated with ramucirumab/paclitaxel: hypertension, proteinuria, gastrointestinal bleeding or perforation, delayed wound healing, deep vein thrombosis, arterial thrombosis, stroke according to on CTCAE v5.0
Measured: Until September 30, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Gastric 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 222 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zang, Dae Young, Hallym University Medical Center
- Investigators
- Dae Young Zang, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915807
- Sponsor's protocol ID
- KCSG ST21-06
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jung KW, Won YJ, Kong HJ, Lee ES. Cancer Statistics in Korea: Incidence, Mortality, Survival, and Prevalence in 2016. Cancer Res Treat. 2019 Apr;51(2):417-430. doi: 10.4143/crt.2019.138. Epub 2019 Mar 18.
PubMed 30913865Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol. 2006 Jun 20;24(18):2903-9. doi: 10.1200/JCO.2005.05.0245.
PubMed 16782930Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
PubMed 20728210Kim HS, Kim HJ, Kim SY, Kim TY, Lee KW, Baek SK, Kim TY, Ryu MH, Nam BH, Zang DY. Second-line chemotherapy versus supportive cancer treatment in advanced gastric cancer: a meta-analysis. Ann Oncol. 2013 Nov;24(11):2850-4. doi: 10.1093/annonc/mdt351. Epub 2013 Aug 13.
PubMed 23942775Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, Dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-39. doi: 10.1016/S0140-6736(13)61719-5. Epub 2013 Oct 3.
PubMed 24094768Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.
PubMed 25240821Smyth EC, Verheij M, Allum W, Cunningham D, Cervantes A, Arnold D; ESMO Guidelines Committee. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v38-v49. doi: 10.1093/annonc/mdw350. No abstract available.
PubMed 27664260Muro K, Van Cutsem E, Narita Y, Pentheroudakis G, Baba E, Li J, Ryu MH, Zamaniah WIW, Yong WP, Yeh KH, Kato K, Lu Z, Cho BC, Nor IM, Ng M, Chen LT, Nakajima TE, Shitara K, Kawakami H, Tsushima T, Yoshino T, Lordick F, Martinelli E, Smyth EC, Arnold D, Minami H, Tabernero J, Douillard JY. Pan-Asian adapted ESMO Clinical Practice Guidelines for the management of patients with metastatic gastric cancer: a JSMO-ESMO initiative endorsed by CSCO, KSMO, MOS, SSO and TOS. Ann Oncol. 2019 Jan 1;30(1):19-33. doi: 10.1093/annonc/mdy502.
PubMed 30475956Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.
PubMed 27342689Guideline Committee of the Korean Gastric Cancer Association (KGCA), Development Working Group & Review Panel. Korean Practice Guideline for Gastric Cancer 2018: an Evidence-based, Multi-disciplinary Approach. J Gastric Cancer. 2019 Mar;19(1):1-48. doi: 10.5230/jgc.2019.19.e8. Epub 2019 Mar 19. No abstract available.
PubMed 30944757Signorovitch JE, Sikirica V, Erder MH, Xie J, Lu M, Hodgkins PS, Betts KA, Wu EQ. Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research. Value Health. 2012 Sep-Oct;15(6):940-7. doi: 10.1016/j.jval.2012.05.004.
PubMed 22999145Signorovitch JE, Wu EQ, Yu AP, Gerrits CM, Kantor E, Bao Y, Gupta SR, Mulani PM. Comparative effectiveness without head-to-head trials: a method for matching-adjusted indirect comparisons applied to psoriasis treatment with adalimumab or etanercept. Pharmacoeconomics. 2010;28(10):935-45. doi: 10.2165/11538370-000000000-00000.
PubMed 20831302
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study for Real-world Data (RWD) of Ramucirumab Plus Paclitaxel in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04915807
- Acronym / sponsor ID
- KCSG ST21-06
- Keywords
- Real-world data, Gastric cancer, Gastroesophageal junction adenocarcinoma, Ramucirumab, Paclitaxel, Chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 7 Jun 2021 (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.
Real World Data (RWD) obtained from real clinical sites is data obtained after administering a drug to patients with different characteristics in daily practice, and Real World Evidence (RWE) is established based on RWD. It is possible to overcome the disadvantage of RCT, which cannot reflect all the various variables in the actual clinical field as it is conducted for only subset of patients.
Researchers planned to prospectively collect RWD of ramucirumab/paclitaxel combination therapy as 2nd-line chemotherapy in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Detailed description
Most drugs are introduced into the medical market based on efficacy derived from randomized controlled trials (RCTs) in a subset of patient groups in which the age, presence of comorbidities, and general conditions of the target patient are strictly controlled by the researcher.
Real World Data (RWD) obtained from real clinical sites is data obtained after administering a drug to patients with different characteristics in daily practice, and Real World Evidence (RWE) is established based on RWD. It is possible to overcome the disadvantage of RCT, which cannot reflect all the various variables in the actual clinical field as it is conducted for only subset of patients.
Researchers have collected retrospective RWD from patients who used ramucirumab/paclitaxel in a previous study (KCSG ST19-16). Considering the limitations of RWD obtained through retrospective data collection, it is necessary to generate RWE through RWD, which prospectively collects various clinical data obtained in the process of using new anticancer drugs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective population | – | Drug: Ramucirumab and paclitaxelThe target group for the purpose of prospectively collecting the clinical data (RWD) of patients using ramucirumab/paclitaxel as 2nd-line chemotherapy in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma |
| Historical retrospective population | – | Drug: Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapyThe target group for the purpose of retrospectively collecting the clinical data (RWD) of patients who have failed platinum-based palliative first-line therapy, and who started the following second-line therapy: taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy, before May 1, 2018, when health insurance coverage for the ramucirumab/paclitaxel combination therapy started in South Korea. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting university hospitals located in major cities in South Korea
Key inclusion criteria (7 listed)
- Patients aged 19 years or older and histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
- Patients with locally advanced or metastatic disease for which curative resection is not possible
- Patients who have failed platinum-based palliative first-line therapy, and who started the following second-line therapy: taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy, before May 1, 2018
Key exclusion criteria (6 listed)
- Historical retrospective population
- Patients receiving ramucirumab monotherapy
- Patients receiving ramucirumab/paclitaxel in clinical trial or receiving without being covered by health insurance
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 |
|---|---|---|
| Ramucirumab and paclitaxelAlso: Prospective populationRamucirumab/paclitaxel as a second-line chemotherapy after May 1, 2018, when health insurance coverage for the combination therapy started | Drug | Prospective population |
| Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapyAlso: Historical retrospective populationTaxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy as a second-line therapy | Drug | Historical retrospective population |
Primary outcome
Overall survival
Time frame: Until September 30, 2023
Time from the start of ramucirumab/paclitaxel to death from any cause
Progression-free survival
Time frame: Until September 30, 2023
Time from the start of ramucirumab/paclitaxel to disease progression or death from any cause
6 secondary outcomes
Incidence of adverse events
Time frame: Until September 30, 2023
Time to progression
Time frame: Until September 30, 2023
Objective response rate
Time frame: Until September 30, 2023
Disease control rate
Time frame: Until September 30, 2023
Duration of response
Time frame: Until September 30, 2023
Adverse events of special interest
Time frame: Until September 30, 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Background: PubMed 30913865Jung KW, Won YJ, Kong HJ, Lee ES. Cancer Statistics in Korea: Incidence, Mortality, Survival, and Prevalence in 2016. Cancer Res Treat. 2019 Apr;51(2):417-430. doi: 10.4143/crt.2019.138. Epub 2019 Mar 18.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 16782930Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol. 2006 Jun 20;24(18):2903-9. doi: 10.1200/JCO.2005.05.0245.
- Background: PubMed 20728210Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
- Background: PubMed 23942775Kim HS, Kim HJ, Kim SY, Kim TY, Lee KW, Baek SK, Kim TY, Ryu MH, Nam BH, Zang DY. Second-line chemotherapy versus supportive cancer treatment in advanced gastric cancer: a meta-analysis. Ann Oncol. 2013 Nov;24(11):2850-4. doi: 10.1093/annonc/mdt351. Epub 2013 Aug 13.
- Background: PubMed 24094768Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, Dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-39. doi: 10.1016/S0140-6736(13)61719-5. Epub 2013 Oct 3.
- Background: PubMed 25240821Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.
- Background: PubMed 27664260Smyth EC, Verheij M, Allum W, Cunningham D, Cervantes A, Arnold D; ESMO Guidelines Committee. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v38-v49. doi: 10.1093/annonc/mdw350. No abstract available.
- Background: PubMed 30475956Muro K, Van Cutsem E, Narita Y, Pentheroudakis G, Baba E, Li J, Ryu MH, Zamaniah WIW, Yong WP, Yeh KH, Kato K, Lu Z, Cho BC, Nor IM, Ng M, Chen LT, Nakajima TE, Shitara K, Kawakami H, Tsushima T, Yoshino T, Lordick F, Martinelli E, Smyth EC, Arnold D, Minami H, Tabernero J, Douillard JY. Pan-Asian adapted ESMO Clinical Practice Guidelines for the management of patients with metastatic gastric cancer: a JSMO-ESMO initiative endorsed by CSCO, KSMO, MOS, SSO and TOS. Ann Oncol. 2019 Jan 1;30(1):19-33. doi: 10.1093/annonc/mdy502.
- Background: PubMed 27342689Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.
- Background: PubMed 30944757Guideline Committee of the Korean Gastric Cancer Association (KGCA), Development Working Group & Review Panel. Korean Practice Guideline for Gastric Cancer 2018: an Evidence-based, Multi-disciplinary Approach. J Gastric Cancer. 2019 Mar;19(1):1-48. doi: 10.5230/jgc.2019.19.e8. Epub 2019 Mar 19. No abstract available.
- Background: PubMed 22999145Signorovitch JE, Sikirica V, Erder MH, Xie J, Lu M, Hodgkins PS, Betts KA, Wu EQ. Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research. Value Health. 2012 Sep-Oct;15(6):940-7. doi: 10.1016/j.jval.2012.05.004.
- Gastric Cancer: NCCN Guidelines Version 2.2021Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Dae Young Zang principal investigator
Hallym University Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Hallym University Medical Center at 9 sites in South Korea.
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 7 inclusion and 6 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 7 Jun 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dae Young Zang (+82-31-380-4167, fhdzang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Until September 30, 2023). The study lists 2 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 NCT04915807, which also lists 13 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 7 Jun 2021.