Chemotherapy Options for the First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer
NCT ID: NCT02114359
Last Updated: 2020-10-23
Study Results
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Basic Information
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COMPLETED
PHASE3
111 participants
INTERVENTIONAL
2014-02-28
2020-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Platinum/fluoropyrimidine combination chemotherapy
Capecitabine/cisplatin
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
S-1/cisplatin
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
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
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
Fluoropyrimidine monochemotherapy
Capecitabine
Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr \<60ml/min, 1000mg/m2 po bid)
S-1
S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr \<60ml/min, 30mg/m2 po bid)
5-fluorouracil
5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks
Interventions
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Capecitabine/cisplatin
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
S-1/cisplatin
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
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
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
Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr \<60ml/min, 1000mg/m2 po bid)
S-1
S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr \<60ml/min, 30mg/m2 po bid)
5-fluorouracil
5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks
Eligibility Criteria
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Inclusion Criteria
* 70 yrs or older
* Eastern Cooperative Oncology Group 0-2
* Measurable or evaluable disease
* Adequate major organ functions
* Hb ≥ 9.0 g/dL
* White blood cell count ≥ 3000/μL
* Absolute Neutrophil Count (ANC) ≥ 1500/μL \[\*ANC = neutrophil segs ＋ neutrophil bands\]
* Platelet ≥ 100 × 103/ μL
* Total bilirubin ≤ 1.5 ×UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3.0x UNL(in case of liver metastasis, AST/ALT ≤ 5.0 x UNL)
* Serum creatinine ≤ 1.5 × UNL (in case of serum creatinine \> 1.5 mg/dL , Ccr should be \>= 50 mL/min, Ccr is calculated by Cockcroft-Gault or 24hr urine collection)
* Life expectancy \> 3month
* Written informed consent
Exclusion Criteria
* HER-2 positive
* Clinically significant, uncontrolled gastric outlet obstruction, bleeding, or perforation
* Radiation therapy within the previous 2wks
* Major surgery or trauma within the previous 4wks
* Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
* Uncontrolled brain metastasis
* Presence of other serious disease (cardiovascular, hepatic, infection etc.)
* Patients who participated in other clinical trials within the previous 30days
* Men of childbearing potential not willing to use effective means of contraception
70 Years
ALL
No
Sponsors
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Ministry of Health & Welfare, Korea
OTHER_GOV
Korean Cancer Study Group
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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In Sil Choi
Clinical Associate Professor, Department of Internal Medicine
Principal Investigators
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IN SIL CHOI, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
SMG-SNU Boramae Medical Center
Locations
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Hallym University Sacred Heart Hospital
Anyang, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Kyungpook National University Medical Center
Daegu, , South Korea
Yeongnam University Medical Center
Daegu, , South Korea
National Cancer Center
Goyang, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Inje University Pusan Paik Hospital
Pusan, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , 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
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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20140113/16-2014-9/021
Identifier Type: -
Identifier Source: org_study_id
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