Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01090505 |
Recruitment Status
: Unknown
Verified November 2009 by Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted
: March 22, 2010
Last Update Posted
: March 22, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer | Drug: Drug: S-1 and oxaliplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced |
Study Start Date : | November 2009 |
Estimated Primary Completion Date : | December 2012 |
Estimated Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Drug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy
|
Drug: Drug: S-1 and oxaliplatin
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Other Names:
|
No Intervention: surgery
Procedure/Surgery: Gastrectomy with D2 dissection
|
Drug: Drug: S-1 and oxaliplatin
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Other Names:
|
- overall survival [ Time Frame: 5 years ]
- response rate [ Time Frame: 3 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090505
Contact: L Chen, MD | 86-10-66938028 | litbj301@sina.com |
China, Beijing | |
China PLA General Hospital | Recruiting |
Beijing, Beijing, China, 100853 | |
Contact: Fu xing road 28# 86-10-66938328 |
Responsible Party: | L Chen, Chinese PLA General Hospital |
ClinicalTrials.gov Identifier: | NCT01090505 History of Changes |
Other Study ID Numbers: |
GC-ChinaPLAGH-2010 |
First Posted: | March 22, 2010 Key Record Dates |
Last Update Posted: | March 22, 2010 |
Last Verified: | November 2009 |
Additional relevant MeSH terms:
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Oxaliplatin Antineoplastic Agents |