Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Chinese PLA General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Chinese PLA General Hospital
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01090505
First received: March 16, 2010
Last updated: March 19, 2010
Last verified: November 2009
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Purpose
The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: Drug: S-1 and oxaliplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced |
Resource links provided by NLM:
MedlinePlus related topics:
Stomach Cancer
Drug Information available for:
Oxaliplatin
U.S. FDA Resources
Further study details as provided by Chinese PLA General Hospital:
Primary Outcome Measures:
- overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- response rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 160 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090505
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090505
Contacts
| Contact: L Chen, MD | 86-10-66938028 | litbj301@sina.com |
Locations
| China, Beijing | |
| China PLA General Hospital | Recruiting |
| Beijing, Beijing, China, 100853 | |
| Contact: Fu xing road 28# 86-10-66938328 | |
Sponsors and Collaborators
Chinese PLA General Hospital
More Information
| Responsible Party: | L Chen, Chinese PLA General Hospital |
| ClinicalTrials.gov Identifier: | NCT01090505 History of Changes |
| Other Study ID Numbers: | GC-ChinaPLAGH-2010 |
| Study First Received: | March 16, 2010 |
| Last Updated: | March 19, 2010 |
| Health Authority: | China: Ethics Committee |
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 |
ClinicalTrials.gov processed this record on September 28, 2016