Clinical trial NCT03601988: Phase III Trial of Adjuvant Chemo-radiotherapy After D2 Surgery of Gastric Cancer
Official title: A Randomized Phase III Trial of Postoperative Chemotherapy or Chemo-radiotherapy for Locally Advanced Gastric Cancer After D2 Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: gastric cancer
radiotherapy
postoperative
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients randomized to receive chemotherapy or chemo-radiotherapy after D2 surgery
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the efficacy of adjuvant radiotherapy for D2 resected gastric cancer

Detailed description: The radiotherapy dose of 45Gy in 25 fractions as adjuvant treatment after D2 surgery for gastric cancer

Eligibility criteria: Inclusion Criteria:

1. Aged 18-75；
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:

1. Previous radiotherapy or chemotherapy；
2. Inadequate organ function;
3. Pregnant or lactating women or women of childbearing potential.

Primary outcomes:
measure: DFS
timeFrame: 36 months
Secondary outcomes:
measure: OS
timeFrame: 36 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xianglin Yuan, MD,PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.