Postoperative Chemoradiotherapy With S-1 in Gastric Cancer

NCT01824004 | Completed Phase 2 DMC

• 2 other identifiers: CNUHH-MO-03CNUHH
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Gastric cancer; Adjuvant; Chemoradiotherapy; S-1; Cisplatin

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  3 years

Secondary Outcomes (2)

• Overall Survival

  3 years

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

  3 year

Other Outcomes (1)

• Health -related quality of life

  6 months after enrollment

Study Arms (1)

S-1,chemoradiotherapy, adjuvant treatment

EXPERIMENTAL

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.

Drug: S-1

Interventions

S-1 DRUG

Also known as: TS-1

S-1,chemoradiotherapy, adjuvant treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Sites (1)

Chonnam National University Hwasun Hospital

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

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); titanium silicide

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Sang-Hee Cho, M.D.Ph.D.

  CNUHH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 4, 2013
• Study Start: April 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: June 1, 2012
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

KR (1)