Postoperative Chemoradiotherapy With S-1 in Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Phase II Study of Adjuvant S-1/Cisplatin Chemotherapy Followed by S-1-based Chemoradiotherapy in Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824004
• Other study ID #: CNUHH-MO-03
• Secondary ID: CNUHH
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2013
• Last updated: April 3, 2013
• Start date: April 2009
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study was conducted to evaluate the clinical outcomes and toxicities of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.

Description:

Surgery is the only possible curative treatment of gastric cancer. However, the high recurrence rate makes gastric cancer a disease difficult to cure by surgery alone. Despite the benefit of CRT on local recurrence, the distant recurrence is the leading pattern of failure. We hypothesized that gastric cancer outcome could be improved using a more effective chemotherapy regimen. This study was conducted to evaluate the clinical outcomes and toxicity of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1 based CRT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Histologically proven gastric adenocarcinoma which is complete resected

• ECOG performance status of 1 or lower

• Adequate bone marrow function

• absolute neutrophil count [ANC] =1,500µL, and platelets =100,000/µL

• Adequate kidney function (serum creatinine < 1.5 mg/dL)

• Adequate liver function (serum total bilirubin < 2 times the upper normal limit (UNL) serum transaminases levels <2 times UNL

• No prior chemotherapy

Exclusion Criteria:

• Other tumor type than adenocarcinoma

• Evidence of distant metastasis

• Past or concurrent history of neoplasm except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri

• Uncontrolled infection

• Unstable cardiac disease despite treatment, myocardial infarction within months prior to study entry

• History of significant neurologic or psychiatric disorders including dementia or seizures

• Other serious underlying medical conditions which could impair the ability of the patient to participate in the study

• Symptoms of gastrointestinal obstruction

• concomitant drug medication: The following drugs cause drug interaction with S-1.

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-Eup	Jeollanam-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health -related quality of life		6 months after enrollment	No
Primary	Disease free survival		3 years	No
Secondary	Overall Survival		3 years	Yes
Secondary	Number of participants with adverse events as a measure of safety and tolerability		3 year	Yes