NCT00323830

Brief Summary

The objective of the trial is to compare disease-free survival between adjuvant capecitabine/cisplatin alone vs capecitabine/cisplatin with radiotherapy (chemoradiation) in curatively resected gastric cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
458

participants targeted

Target at P50-P75 for phase_3 gastric-cancer

Timeline
Completed

Started Oct 2004

Typical duration for phase_3 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

3.5 years

First QC Date

May 8, 2006

Last Update Submit

November 8, 2011

Conditions

Gastric CancerSurgery

Keywords

gastric cancerradiotherapypostoperative therapychemotherapy

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    3-year

Study Arms (2)

capecitabine/cisplatin/radiotherapy

EXPERIMENTAL

postoperative XP/RT

Drug: Capecitabine, cisplatin, Radiotherapy (+/-)

capecitabine/cisplatin

ACTIVE COMPARATOR

postoperative XP

Drug: Capecitabine, cisplatin, Radiotherapy (+/-)

Interventions

Capecitabine, cisplatin, Radiotherapy (+/-)DRUG

Capecitabine, cisplatin + Radiotherapy (randomized)

capecitabine/cisplatincapecitabine/cisplatin/radiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven gastric adenocarcinoma
  • ≥ D2 resection
  • Stage IB(T1N1,T2bN0), II, IIIA, IIIB, IV(T4,N3 포함, M1 lymph node 제외)
  • ≤ age ≤ 75
  • ECOG 0-2
  • No distant metastasis
  • Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl)
  • Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
  • liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
  • Written informed consent

You may not qualify if:

  • Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer
  • Active infection requiring antibiotics
  • Pregnant, lactating women
  • Psychiatric illness, epileptic disorders
  • Concurrent systemic illness not appropriate for chemotherapy
  • Resection margin (+)
  • Pathologic stage IA
  • History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
  • M1 lymph node (+)
  • D0, D1 resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Park SH, Sohn TS, Lee J, Lim DH, Hong ME, Kim KM, Sohn I, Jung SH, Choi MG, Lee JH, Bae JM, Kim S, Kim ST, Park JO, Park YS, Lim HY, Kang WK. Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses. J Clin Oncol. 2015 Oct 1;33(28):3130-6. doi: 10.1200/JCO.2014.58.3930. Epub 2015 Jan 5.

    PMID: 25559811DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

CapecitabineCisplatinRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Study Officials

  • Won Ki Kang, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Study Record Dates

First Submitted

May 8, 2006

First Posted

May 10, 2006

Study Start

October 1, 2004

Primary Completion

April 1, 2008

Study Completion

April 1, 2011

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

KR(1)