Postoperative Chemoradiotherapy With S-1 in Gastric Cancer

NCT ID: NCT01824004

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-06-30

Brief 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.

Detailed 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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-1,chemoradiotherapy, adjuvant treatment

Pts with radically D2 resected adenocarcinoma of the stomach or GEJ in AJCC stage Ib-IV (M0) were eligible for this study. Pts were treated with S-1 (40-60 mg depending on BSA) b.i.d. for 3 wks, and cisplatin (60 mg/m²) iv on day 1, followed by a 2-wk rest period, within a 5-wk cycle. Subsequently, radiotherapy (RT) started which consisted of 25 fractions of 1.8 Gy to a total dose of 45 Gy in 5 wks (5 fractions/wk). On RT days, S-1 (40-60 mg depending on BSA ) b.i.d., 5 days/wk was given. One month after the completion of RT, two 5-wk cycles of S-1/ciplatin chemotherapy were given.

Group Type: EXPERIMENTAL

S-1

Intervention Type: DRUG

Interventions

S-1

Intervention Type: DRUG

Other Intervention Names

TS-1

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chonnam National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang-Hee Cho

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang-Hee Cho, M.D.Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CNUHH

Locations

Chonnam National University Hwasun Hospital

Hwasun-Eup, Jeollanam-do, South Korea

Countries

South Korea

Other Identifiers

CNUHH

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CNUHH-MO-03

Identifier Type: -

Identifier Source: org_study_id