NCT00296335

Brief Summary

This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
855

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_3

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

February 1, 2002

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

February 27, 2014

Completed
Last Updated

February 27, 2014

Status Verified

January 1, 2014

Enrollment Period

5.8 years

First QC Date

February 24, 2006

Results QC Date

November 12, 2013

Last Update Submit

January 13, 2014

Conditions

Stomach Cancer

Keywords

Stomach cancerAdjuvant chemotherapyMitomycinCisplatinDoxifluridine

Outcome Measures

Primary Outcomes (1)

  • Relapse-free Survival Rate

    Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery. Relapse was defined as any new tumor lesion.

    3 years

Secondary Outcomes (2)

  • Overall Survival Rate

    3 years

  • Number of Patients With Adverse Events

    Up to 3 years

Study Arms (2)

Mitomycin and doxifluridine

ACTIVE COMPARATOR

Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)

Drug: Mitomycin and doxifluridine

Mitomycin, doxifluridine and cisplatin

EXPERIMENTAL

Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)

Drug: Mitomycin, doxifluridine and cisplatin

Interventions

Mitomycin, doxifluridine and cisplatinDRUG

Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)

Mitomycin, doxifluridine and cisplatin
Mitomycin and doxifluridineDRUG

Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)

Mitomycin and doxifluridine

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically proven gastric adenocarcinoma
  • Curative resection was done
  • stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis)
  • age: 18-69 years old
  • Performance status: ECOG 0-2
  • Adequate bone marrow function (WBC ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl)
  • Adequate renal function (serum creatinine≤ 1.5)
  • Adequate liver function (serum bilirubin ≤1.5 mg/dl, AST/ALT ≤ 3 x normal upper limit)
  • Written informed consent was signed by the patient

You may not qualify if:

  • Previous chemotherapy or radiotherapy
  • Active ongoing infection which antibiotic treatment is needed
  • Pregnant or lactating women
  • Psychosis or convulsion disorder
  • Ascites in preoperative abdomen CT
  • Systemic disease which interfere the administration of chemotherapy
  • Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

MitomycindoxifluridineCisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Results Point of Contact

Title
Dr. Yoon-Koo Kang
Organization
Asan Medical Center
ykkang@amc.seoul.kr
+82-2-3010-3210

Study Officials

  • Yoon-Koo Kang, M.D.,Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 27, 2006

Study Start

February 1, 2002

Primary Completion

November 1, 2007

Study Completion

December 1, 2009

Last Updated

February 27, 2014

Results First Posted

February 27, 2014

Record last verified: 2014-01

Locations

KR(1)