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

Yonsei University logo

Yonsei University

Status and phase

Terminated
Phase 2

Conditions

Advanced Gastric Cancer

Treatments

Drug: S-1 plus oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01946061
4-2013-0452

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

Treatment group
Experimental group
Treatment:
Drug: S-1 plus oxaliplatin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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