Phase III Trial of Adjuvant Chemo-radiotherapy After D2 Surgery of Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Randomized Phase III Trial of Postoperative Chemotherapy or Chemo-radiotherapy for Locally Advanced Gastric Cancer After D2 Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03601988
• Other study ID #: TJCC007
• Status: Recruiting
• Phase: Phase 3
• Start date: July 28, 2018
• Est. completion date: July 28, 2022

Study information

• Verified date: July 2018
• Source: Huazhong University of Science and Technology
• Contact: Xianglin Yuan, MD,PhD
• Phone: 8627-83663406
• Email: xlyuan1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: July 28, 2022
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Radiation:
• 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

Drug:
• Chemotherapy
Chemotherapy group receive 8 cycles of XELOX.

Locations

Country	Name	City	State
China	Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum in: N Engl J Med. 2008 May 1;358(18):1977. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months	36 months
Secondary	OS	From date of randomization until the date of first documented death from any cause, assessed up to 36 months	36 months