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Postoperative Chemoradiotherapy With S-1 in Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-1
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Adjuvant, Chemoradiotherapy, S-1, Cisplatin

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chonnam National University Hwasun Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-1,chemoradiotherapy, adjuvant treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

Overall Survival
Number of participants with adverse events as a measure of safety and tolerability

Full Information

First Posted
March 28, 2013
Last Updated
April 3, 2013
Sponsor
Chonnam National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01824004
Brief Title
Postoperative Chemoradiotherapy With S-1 in Gastric Cancer
Official Title
A Phase II Study of Adjuvant S-1/Cisplatin Chemotherapy Followed by S-1-based Chemoradiotherapy in Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, Adjuvant, Chemoradiotherapy, S-1, Cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-1,chemoradiotherapy, adjuvant treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
TS-1
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
3 year
Other Pre-specified Outcome Measures:
Title
Health -related quality of life
Time Frame
6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Hee Cho, M.D.Ph.D.
Organizational Affiliation
CNUHH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-Eup
State/Province
Jeollanam-do
ZIP/Postal Code
519-809
Country
Korea, Republic of

12. IPD Sharing Statement

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Postoperative Chemoradiotherapy With S-1 in Gastric Cancer

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