Stomach Neoplasms Clinical Trial
Official title:
Randomized Phase 3 Study of Xelox(Capecitabine Plus Oxaliplatin) Followed by Maintenance Capecitabine or Observation in Patients With Advanced Gastric Adenocarcinoma
XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. We study that randomized Phase III study of Xelox (Capecitabine plus Oxaliplatin) followed by maintenance Capecitabine or Observation in the gastric cancer patients of stable disease after 6 cycle 1st line of XELOX chemotherapy .
Status | Recruiting |
Enrollment | 184 |
Est. completion date | January 2019 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically proven gastric cancer - 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 were exposed previously to any chemotherapy except XELOX for advanced disease - 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Buchon St. Mary's Hospital | Buchon | |
Korea, Republic of | Daejeon St. Mary's Hospital | Daejeon | |
Korea, Republic of | Incheon St. Mary's Hospital | Incheon | |
Korea, Republic of | Seoul St. Mary's Hospital | Seoul | |
Korea, Republic of | St. Mary's Hospital | Seoul | |
Korea, Republic of | Bundang Seoul National hospital | Sungnam | |
Korea, Republic of | St. Vincent's Hospital | Suwon | Gyeonggi-do |
Korea, Republic of | Ujeongbu St. Mary's Hospital | Ujeongbu |
Lead Sponsor | Collaborator |
---|---|
The Catholic University of Korea |
Korea, Republic of,
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. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2007 May 24. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression | From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years | |
Secondary | Overall survival | every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until death | From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years | |
Secondary | quality of life in patients measured by QLQ-c30 and STO-22 | every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression | From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years | |
Secondary | Toxicity profile of each patients measured by NCI-CTCAE ver 4.0 | every two cycles (6 weeks) until 18 weeks and then every 4 cycles (12 weeks) until progression | From date of randomization until the date of first documented progression, whichever came first, assessed up to 2 years |
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