Trials Sponsors Conditions Drugs Pricing

Conditions

Phase I: To Determine the Maximum Tolerated Dose (MTD)Phase II: To Assess the Pathologic CR Rate and Feasibility Following Neoadjuvant Chemoradiation Therapy With S1/Oxaliplatin

Outcome Measures

Primary Outcomes (1)

MTD/pathologic CR
at the time of surgery

Study Arms (1)

S-1/oxaliplatin/RT

EXPERIMENTAL

Radiotherapy + 4 dose levels of oxaliplatin/S-1

Drug: Oxaliplatin, S-1, radiotherapy

Interventions

Oxaliplatin, S-1, radiotherapyDrug

Radiotherapy 4000cGy/20 fractions S-1 ( )mg/m2 po bid daily during radiotherapy Oxaliplatin at four dose levels (\_\_\_mg/m2 iv weekly x 4 weeks)

S-1/oxaliplatin/RT

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Treatment and procedure
Oxaliplatin, S-1, radiotherapy
The registry names a treatment alongside a procedure. This entry does not establish their timing or actual administration.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients older than 18 years
Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma ③ Localized gastric cancer of clinical stage (T2N(+), T3/T4)

Sponsors & Collaborators

Samsung Medical Center
Otherlead

Study Sites (1)

Samsung Cancer Center

Seoul, South Korea

MeSH Terms

Interventions

OxaliplatinS 1 (combination)Radiotherapy

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTherapeutics

Study Officials

Won Ki Kang, MD
Samsung Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

April 15, 2010

First Posted

April 19, 2010

Study Start

March 2009

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer: Randomized Phase II Study of S-1/RT vs. S-1/Oxaliplatin/RT

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

S-1/oxaliplatin/RT

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

S-1/oxaliplatin/RT

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations