Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer

C

Chinese PLA General Hospital (301 Hospital)

Status and phase

Unknown
Phase 2

Conditions

Gastric Cancer

Treatments

Drug: Drug: S-1 and oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01090505
GC-ChinaPLAGH-2010

Details and patient eligibility

About

The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.

Enrollment

160 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)

  • Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
  • Age:20 to 75
  • Performance status:ECOG 0-2
  • Life expectancy:Not specified
  • Hematopoietic:WBC 4,000-12,000/mm^3;Granulocyte count ≥ 2,000/mm^3;Platelet count ≥ 100,000/mm^3;Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L;Bilirubin ≤ 1.5 mg/dL
  • Adequate organ function
  • Able to swallow oral medication
  • Written informed consent

Exclusion criteria

  • Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
  • Pregnant or breast-feeding women
  • Severe mental disease
  • Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
  • Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
  • Myocardial infarction within six disease-free months

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Experimental group
Description:
Drug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy
Treatment:
Drug: Drug: S-1 and oxaliplatin
surgery
No Intervention group
Description:
Procedure/Surgery: Gastrectomy with D2 dissection
Treatment:
Drug: Drug: S-1 and oxaliplatin

Trial contacts and locations

0

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Central trial contact

L Chen, MD

Data sourced from clinicaltrials.gov

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