Phase III Trial of Adjuvant Chemo-radiotherapy After D2 Surgery of Gastric Cancer
NCT ID: NCT03601988
Last Updated: 2018-07-26
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
408 participants
INTERVENTIONAL
2018-07-28
2022-07-28
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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Chemotherapy
Adjuvant chemotherapy group receive 8 cycles of XELOX (Oxaliplatin 130mg/m2, ivdrip, D1,capecitabine 1000mg po, Bid, D1-14, Q21D)
Chemotherapy
Chemotherapy group receive 8 cycles of XELOX.
Chemo-radiotherapy
Adjuvant chemo-radiotherapy group receive 6 cycles of XELOX (Oxaliplatin 130mg/m2, ivdrip, D1, capecitabine 1000mg po, Bid, D1-14, Q21D) and concurrent chemo-radiotherapy (capecitabine 825mg po, Bid, d1-5, QW)
Concurrent chemo-radiotherapy
Experimental group receive 6 cycles of XELOX chemotherapy and concurrent chemo-radiotherapy. The radiotherapy dose of 45Gy in 25 fractions delivered by IMRT Radiotherapy
Interventions
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Concurrent chemo-radiotherapy
Experimental group receive 6 cycles of XELOX chemotherapy and concurrent chemo-radiotherapy. The radiotherapy dose of 45Gy in 25 fractions delivered by IMRT Radiotherapy
Chemotherapy
Chemotherapy group receive 8 cycles of XELOX.
Eligibility Criteria
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Inclusion Criteria
2. Had histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction；
3. ECOG 0-1；
4. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
5. D2 and R0 resection;
6. Locally advanced (UICC stage, T4, N2, N3) gastric cancer after surgery;
7. More than 15 lymph nodes;
8. Adequate organ function as defined below: Hematologic ANC ≥ 2\*109/L, Platelets ≥ 100\*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.
Exclusion Criteria
2. Inadequate organ function;
3. Pregnant or lactating women or women of childbearing potential.
18 Years
75 Years
ALL
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Xianglin Yuan
Professor, Head of the cancer center
Principal Investigators
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Xianglin Yuan, MD,PhD
Role: STUDY_CHAIR
Tongji Hospital
Locations
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Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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Park SH, Sohn TS, Lee J, Lim DH, Hong ME, Kim KM, Sohn I, Jung SH, Choi MG, Lee JH, Bae JM, Kim S, Kim ST, Park JO, Park YS, Lim HY, Kang WK. Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses. J Clin Oncol. 2015 Oct 1;33(28):3130-6. doi: 10.1200/JCO.2014.58.3930. Epub 2015 Jan 5.
Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.
Noh SH, Park SR, Yang HK, Chung HC, Chung IJ, Kim SW, Kim HH, Choi JH, Kim HK, Yu W, Lee JI, Shin DB, Ji J, Chen JS, Lim Y, Ha S, Bang YJ; CLASSIC trial investigators. Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1389-96. doi: 10.1016/S1470-2045(14)70473-5. Epub 2014 Oct 15.
Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187.
Kim Y, Park SH, Kim KM, Choi MG, Lee JH, Sohn TS, Bae JM, Kim S, Lee SJ, Kim ST, Lee J, Park JO, Park YS, Lim HY, Kang WK. The Influence of Metastatic Lymph Node Ratio on the Treatment Outcomes in the Adjuvant Chemoradiotherapy in Stomach Tumors (ARTIST) Trial: A Phase III Trial. J Gastric Cancer. 2016 Jun;16(2):105-10. doi: 10.5230/jgc.2016.16.2.105. Epub 2016 Jun 24.
Lee J, Lim DH, Kim S, Park SH, Park JO, Park YS, Lim HY, Choi MG, Sohn TS, Noh JH, Bae JM, Ahn YC, Sohn I, Jung SH, Park CK, Kim KM, Kang WK. Phase III trial comparing capecitabine plus cisplatin versus capecitabine plus cisplatin with concurrent capecitabine radiotherapy in completely resected gastric cancer with D2 lymph node dissection: the ARTIST trial. J Clin Oncol. 2012 Jan 20;30(3):268-73. doi: 10.1200/JCO.2011.39.1953. Epub 2011 Dec 19.
Other Identifiers
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TJCC007
Identifier Type: -
Identifier Source: org_study_id
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