A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer

Advanced Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01946061
• Other study ID #: 4-2013-0452
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2013
• Last updated: August 18, 2016
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients could underwent curative surgery. In those, about 60% of patients would survive after 5 years from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric cancer patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age, between 19 and 75

• Histologically proven advanced gastric cancer

• R0 resection after D2 gastrectomy

• Stage III (according to the AJCC 7th criteria)

• ECOG status 0 to 2

Exclusion Criteria:

• Malignancy history other than gastric cancer

• Previous chemotherapy history for gastric cancer

• Previous radiotherapy history for gastric cancer

• Pregnancy or breast milk feeding

• Grade 3 or more of neuropathy

• Active infection

• Severe hepatic dysfunction

• Severe renal dysfunction

• Severe bone marrow dysfunction

• Significant neurologic or psychologic disease

• Inadequate condition for receiving chemotherapy due to significant systemic disease

• Patients who receives drugs which can be interacted with S-1

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1 plus oxaliplatin
Patients will receive adjuvant chemotherapy of eight 3-week cycles of oral S-1 (70 mg/m2/day on days 1 to 14 of each cycle) plus intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) for 6 months after D2 gastrectomy.

Locations

Country	Name	City	State
Korea, Republic of	Severnace Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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	3-year disease-free survival	3-year disease-free survival will be assessed by imaging study including CT and PET.	3 years from the surgery	Yes