Real-world Data (RWD) of Ramucirumab Plus Paclitaxel
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Drug: Ramucirumab and paclitaxel
Ramucirumab/paclitaxel as a second-line chemotherapy after May 1, 2018, when health insurance coverage for the combination therapy started
Other Names:
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| 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. |
Drug: Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy
Taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy as a second-line therapy
Other Names:
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Outcome Measures
Primary Outcome Measures
- Overall survival [Until September 30, 2023]
Time from the start of ramucirumab/paclitaxel to death from any cause
- Progression-free survival [Until September 30, 2023]
Time from the start of ramucirumab/paclitaxel to disease progression or death from any cause
Secondary Outcome Measures
- Incidence of adverse events [Until September 30, 2023]
Number (percentage) of subjects reporting adverse events according to CTCAE v5.0
- Time to progression [Until September 30, 2023]
Time from the start of ramucirumab/paclitaxel to disease progression
- Objective response rate [Until September 30, 2023]
The proportion of subjects confirmed complete or partial response according to RECIST v1.1
- Disease control rate [Until September 30, 2023]
The proportion of subjects confirmed complete response, partial response or stable disease according to RECIST v1.1
- Duration of response [Until September 30, 2023]
Time from documentation of tumor response to disease progression
- Adverse events of special interest [Until September 30, 2023]
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
Eligibility Criteria
Criteria
- Prospective population
Inclusion Criteria:
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Patients aged 19 years or older and histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
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Patients with locally advanced or metastatic disease for which curative resection is not possible.
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Patients who have failed fluoropyrimidine and platinum (cisplatin or oxaliplatin)-based chemotherapy as palliative first-line therapy
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Patients who is starting ramucirumab/paclitaxel combination therapy after the study initiation date
Exclusion Criteria:
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Patients receiving ramucirumab monotherapy
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Patients receiving ramucirumab/paclitaxel in clinical trial or receiving without being covered by health insurance
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Patients unable to communicate or incapable of understanding documents for patient report outcomes
- Historical retrospective population
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Patients receiving ramucirumab monotherapy
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Patients receiving ramucirumab/paclitaxel in clinical trial or receiving without being covered by health insurance
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hallym University Sacred Heart Hospital | Anyang | Korea, Republic of | 14068 | |
| 2 | Kyungpook National University Chilgok Hospital | Daegu | Korea, Republic of | 41404 | |
| 3 | Keimyung University Dongsan Medical Center | Daegu | Korea, Republic of | 42601 | |
| 4 | Seoul National University Bundang Hospital | Seongnam | Korea, Republic of | 13620 | |
| 5 | Kyung Hee University Hospital | Seoul | Korea, Republic of | 02447 | |
| 6 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
| 7 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
| 8 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 9 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 |
Sponsors and Collaborators
- Hallym University Medical Center
Investigators
- Principal Investigator: Dae Young Zang, Hallym University Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Gastric Cancer: NCCN Guidelines Version 2.2021
- C. Goodman. 2014. HTA101 (HTA 101 INTRODUCTION TO HEALTH TECHNOLOGY ASSESSMENT)
- NICE Decision Support Unit. 2017. Technical Support Document 19. Partitioned Survival Analysis For Decision modelling in Health Care: A Critical Review
Publications
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- Bray 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. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313.
- Fuchs 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.
- Guideline 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. Review. Erratum in: J Gastric Cancer. 2019 Sep;19(3):372-373.
- Japanese 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.
- 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.
- Kim 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.
- Muro 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.
- Signorovitch 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.
- Signorovitch 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.
- Smyth 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.
- Wagner 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. Review.
- Wilke 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.
- KCSG ST21-06