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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
| Korean Cancer Study Group | OTHER |
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The investigators compare the overall survival between combination chemotherapy and monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. The investigators also compare the progression free survival, response rate, safety, and, quality of life between two groups, and evaluate that the comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance of treatment, survival of the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platinum/fluoropyrimidine combination chemotherapy | Experimental |
| |
| Fluoropyrimidine monochemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine/cisplatin | Drug | Capecitabine/cisplatin (XP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv over 15min D1, capecitabine 1000mg/m2 (80% dose of 1250mg/m2) po bid D1-14, q 3wks |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of overall survival | upto 3years |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of progression-free survival | upto 2years | |
| comparison of response rate | upto 2years | |
| comparison of adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| comprehensive geriatric assessment | The investigators are going to evaluate that comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance to treatment, survival of patients. Comprehensive geriatric assessment will not necessarily be tested in all subjects, but instead, screening tool (KG-7 (Korean screening tool for the elderly)) will be tested in all subjects. | baseline |
Inclusion Criteria:
.Metastatic or recurrent, histologically confirmed adenocarcinoma of stomach - Previously untreated patients, including patients with previous adjuvant chemotherapy completed more than 6 months
70 yrs or older
Eastern Cooperative Oncology Group 0-2
Measurable or evaluable disease
Adequate major organ functions
Life expectancy > 3month
Written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| IN SIL CHOI, M.D., Ph.D. | SMG-SNU Boramae Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | 431-796 | South Korea | |||
| Inje University Haeundae Paik Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8508349 | Background | Kim NK, Park YS, Heo DS, Suh C, Kim SY, Park KC, Kang YK, Shin DB, Kim HT, Kim HJ, et al. A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer. 1993 Jun 15;71(12):3813-8. doi: 10.1002/1097-0142(19930615)71:123.0.co;2-5. | |
| 12506170 |
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| S-1/cisplatin | Drug | S-1/cisplatin (SP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv ov 15min D1, S-1 30mg/m2 (80% dose of 40mg/m2) po bid D1-14, q3wks |
|
| Capecitabine/oxaliplatin | Drug | Capecitabine+oxaliplatin (XELOX): oxaliplatin 100mg/m2 (80% dose of 130mg/m2)iv ov 120min D1, capecitabine 800mg/m2 (80% dose of 1000mg/m2) po bid D1-14, q3wks |
|
| 5-fluorouracil/oxaliplatin | Drug | 5-fluorouracil/oxaliplatin (FOLFOX): oxaliplatin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, leucovorin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, 5-fluorouracil 1900mg/m2 (80% dose of 2400mg/m2) iv ov 46h D1, q 2wks |
|
| Capecitabine | Drug | Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 1000mg/m2 po bid) |
|
| S-1 | Drug | S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 30mg/m2 po bid) |
|
| 5-fluorouracil | Drug | 5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks |
|
| upto 2yrs |
| comparison of quality of life | upto 2years |
| Busan |
| South Korea |
| Chungbuk National University Hospital | Cheongju-si | 361-711 | South Korea |
| Kyungpook National University Medical Center | Daegu | 702-210 | South Korea |
| Yeongnam University Medical Center | Daegu | South Korea |
| National Cancer Center | Goyang | 410-769 | South Korea |
| Gachon University Gil Medical Center | Incheon | 400-713 | South Korea |
| Inje University Pusan Paik Hospital | Pusan | 614-735 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 463-707 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 156-707 | South Korea |
| Inje University Sanggye Paik Hospital | Seoul | South Korea |
| Kangbuk Samsung Hospital | Seoul | South Korea |
| The Catholic University of Korea Uijeongbu St. Mary's Hospital | Uijeongbu-si | South Korea |
| Ohtsu A, Shimada Y, Shirao K, Boku N, Hyodo I, Saito H, Yamamichi N, Miyata Y, Ikeda N, Yamamoto S, Fukuda H, Yoshida S; Japan Clinical Oncology Group Study (JCOG9205). Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205). J Clin Oncol. 2003 Jan 1;21(1):54-9. doi: 10.1200/JCO.2003.04.130. |
| 10894863 | Background | Vanhoefer U, Rougier P, Wilke H, Ducreux MP, Lacave AJ, Van Cutsem E, Planker M, Santos JG, Piedbois P, Paillot B, Bodenstein H, Schmoll HJ, Bleiberg H, Nordlinger B, Couvreur ML, Baron B, Wils JA. Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: A trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. J Clin Oncol. 2000 Jul;18(14):2648-57. doi: 10.1200/JCO.2000.18.14.2648. |
| 1801881 | Background | Lacave AJ, Baron FJ, Anton LM, Estrada E, De Sande LM, Palacio I, Esteban E, Gracia JM, Buesa JM, Fernandez OA, et al. Combination chemotherapy with cisplatin and 5-fluorouracil 5-day infusion in the therapy of advanced gastric cancer: a phase II trial. Ann Oncol. 1991 Nov-Dec;2(10):751-4. doi: 10.1093/oxfordjournals.annonc.a057858. |
| 19153121 | Background | Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009 Apr;20(4):666-73. doi: 10.1093/annonc/mdn717. Epub 2009 Jan 19. |
| 18282805 | Background | Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. doi: 10.1016/S1470-2045(08)70035-4. Epub 2008 Feb 20. |
| 18172173 | Background | Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149. |
| 18665164 | Background | Lee JL, Kang YK, Kang HJ, Lee KH, Zang DY, Ryoo BY, Kim JG, Park SR, Kang WK, Shin DB, Ryu MH, Chang HM, Kim TW, Baek JH, Min YJ. A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer. Br J Cancer. 2008 Aug 19;99(4):584-90. doi: 10.1038/sj.bjc.6604536. Epub 2008 Jul 29. |
| 10765119 | Background | Koizumi W, Kurihara M, Nakano S, Hasegawa K. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. For the S-1 Cooperative Gastric Cancer Study Group. Oncology. 2000 Apr;58(3):191-7. doi: 10.1159/000012099. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D002945 | Cisplatin |
| C000711476 | S-1 plus cisplatin |
| C519688 | XELOX |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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