Phase 3 Study of Xelox Followed by Maintenance Capecitabine in the Advanced Gastric Cancer
NCT ID: NCT02289547
Last Updated: 2017-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
184 participants
INTERVENTIONAL
2015-05-31
2019-01-31
Brief Summary
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Detailed Description
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\- Objective: Primary: To evaluate progression free survival Secondary: To evaluated overall survival, response rate, toxicity profile of chemotherapy, quality of life
* Design :Multicenter randomized controlled phase III open label trial Study subjects will be randomized to two groups in a ratio of 1:1 Subjects More than stable disease after 6 cycle 1st line of XELOX chemotherapy (OR non-complete response/non-progressive disease in cases of non-measurable disease before XELOX chemotherapy),
* Treatment Groups Group A : Capecitabine: Capecitabine 1000mg/m2 bid D1-14, q 3 week Group B : Observation
* Evaluation of response and toxicity A response will be evaluated radiologically every two cycles thereafter, or when progression is suspicious by RECIST criteria version 1.1.
A progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression or death due to any cause.
An overall survival is defined as the time from the 1stdate of chemotherapy to the date of death.
Safety will be evaluated every treatment by NCI-CTCAE version 4.0.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
observational arm
No interventions assigned to this group
Group B
arm of capecitabine maintenance treatment
Capecitabine
maintenance capecitabine therapy after six cycles of XELOX
Interventions
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Capecitabine
maintenance capecitabine therapy after six cycles of XELOX
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Minimum age of 18 years
* Stage IV (regardless of the presence or absence of measurable disease by RECIST criteria) or recurrent after curative surgery
* Negative expression (0, 1) of Her2 Immuno-histochemistry or negative amplification of FISH in Her2 Immuno-histochemistry 2+
* More than stable disease after 6 cycle 1st line of XELOX chemotherapy (OR non-Complete response/non-Progressive disease in cases of non-measurable disease before XELOX chemotherapy)
* Eastern Cooperative Oncology Group Performance status 0-2
* Adequate bone marrow function: Absolute neutrophil count ≥ 1,500/ul, Hemoglobin ≥ 8 g/dL, platelet ≥ 100,000/μl
* Adequate renal function: Serum creatinine ≤ 1.5 x ULN (upper normal limit) or creatinine clearance ≥ 60 ml/min
* Adequate hepatic function: serum bilirubin ≤ 2.5 x UNL, AST and ALT ≤ 2.5 x UNL (≤ 5 x ULN in the presence of liver metastasis)
* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
Exclusion Criteria
* Patients who received R0 or R1 resection for metastatic or recurrent gastric cancer and without evaluable/measurable disease
* Disease relapsed during or within 4 months after adjuvant therapy
* Patients who had central nervous system and meningeal metastases
* Patients with significant neurologic or psychiatric disorders
* Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
* Any previous or concurrent malignancy except for adequately treated non-melanoma skin cancer, in situ cancer of uterine cervix, non-muscle invasive bladder cancer or malignancy without evidence of recurrence within 5 years
18 Years
ALL
No
Sponsors
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The Catholic University of Korea
OTHER
Responsible Party
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Byoungyong Shim
Associated professor
Principal Investigators
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Byoungyong Shim, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
St.Vincent's Hospital of The Catholic University of Korea
Young Seon Hong, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hopital of The Catholic Univerisity of Korea
In Sook Woo, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
St. Mary's Hospital of The Catholic University of Korea
Jae Ho Byun, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Incheon St. Mary's Hopital of The Catholic Univerisity of Korea
Cuk Jin Lee, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Bucheon St. Mary's Hopital of The Catholic Univerisity of Korea
Ji Chan Park, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Daejeon St. Mary's Hopital of The Catholic Univerisity of Korea
Yoon Ho Ko, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Ujeongbu St. Mary's Hopital of The Catholic Univerisity of Korea
Keun Wook Lee, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Bundang Seoul National Hospital
Locations
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St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Buchon St. Mary's Hospital
Buchon, , South Korea
Daejeon St. Mary's Hospital
Daejeon, , South Korea
Incheon St. Mary's Hospital
Incheon, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
St. Mary's Hospital
Seoul, , South Korea
Bundang Seoul National hospital
Sungnam, , South Korea
Ujeongbu St. Mary's Hospital
Ujeongbu, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Byoungyong Shim, Ph.D., M.D
Role: primary
Cuk Jin Lee
Role: primary
Ji Chan Park
Role: primary
Jeo Ho Byen
Role: primary
Young Seon Hong
Role: primary
In Sook Woo
Role: primary
Keun Wook Lee
Role: primary
Yoon Ho Ko
Role: primary
References
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De Vita F, Orditura M, Matano E, Bianco R, Carlomagno C, Infusino S, Damiano V, Simeone E, Diadema MR, Lieto E, Castellano P, Pepe S, De Placido S, Galizia G, Di Martino N, Ciardiello F, Catalano G, Bianco AR. A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients. Br J Cancer. 2005 May 9;92(9):1644-9. doi: 10.1038/sj.bjc.6602573.
Park YH, Lee JL, Ryoo BY, Ryu MH, Yang SH, Kim BS, Shin DB, Chang HM, Kim TW, Yuh YJ, Kang YK. Capecitabine in combination with Oxaliplatin (XELOX) as a first-line therapy for advanced gastric cancer. Cancer Chemother Pharmacol. 2008 Apr;61(4):623-9. doi: 10.1007/s00280-007-0515-7. Epub 2007 May 24.
Waddell T, Gollins S, Soe W, Valle J, Allen J, Bentley D, Morris J, Lloyd A, Swindell R, Taylor MB, Saunders MP. Phase II study of short-course capecitabine plus oxaliplatin (XELOX) followed by maintenance capecitabine in advanced colorectal cancer: XelQuali study. Cancer Chemother Pharmacol. 2011 May;67(5):1111-7. doi: 10.1007/s00280-010-1322-0. Epub 2010 Jul 30.
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.
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 GJ, Kim H, Cho SS, Park HS, An HJ, Woo IS, Byun JH, Hong JH, Ko YH, Sun S, Won HS, Jin JY, Park JC, Kim IH, Roh SY, Shim BY. A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation. J Gastric Cancer. 2023 Apr;23(2):315-327. doi: 10.5230/jgc.2023.23.e16.
Other Identifiers
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CMCGA1 Trial
Identifier Type: -
Identifier Source: org_study_id
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