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Completed

NCT Number: NCT01824004

Postoperative Chemoradiotherapy With S-1 in Gastric Cancer

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonnam National University Hwasun Hospital

Hwasun-Eup, Jeollanam-do, 519-809, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S-1

Drug

Other names: TS-1

Primary outcomes

  1. Disease free survival

    Time frame: 3 years

Secondary outcomes

  1. Overall Survival

    Time frame: 3 years

  2. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: 3 year

Other outcomes

  1. Health -related quality of life

    Time frame: 6 months after enrollment

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Apr 4, 2013
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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