NCT01138904

Brief Summary

FOLFOX\* followed by FOLFIRI\*\* or reverse sequence treatment regimen have been used as a standard treatment modality in metastatic colorectal cancer.Oxaliplatin and Irinotecan were used for advanced gastric cancer also. The investigators study was designed to evaluate the safety and efficacy of FOLFOX followed by FOLFIRI or reverse sequence treatment regimen as a first-line and second line therapy for patients with relapsed or metastatic gastric cancer similar with colorectal cancer. \*FOLFOX: oxaliplatin followed by leucovorin before bolus 5-FU followed by continuous infusion 5-FU \*\*FOLFIRI: irinotecan followed by leucovorin before bolus 5-FU followed by continuous infusion 5-FU

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Timeline
Completed

Started Sep 2009

Typical duration for phase_2 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

September 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

4 years

First QC Date

June 4, 2010

Last Update Submit

November 2, 2014

Conditions

Gastric Cancer

Keywords

gastric canceroxaliplatinirinotecansequential treatment

Outcome Measures

Primary Outcomes (1)

  • Response rate by RECIST

    6 month after treatment

Secondary Outcomes (2)

  • progression free survival

    1 year after start

  • overall survival

    2 years after start

Study Arms (2)

IROX arm: FOLFIRI -> FOLFOX

ACTIVE COMPARATOR

IROX arm: FOLFIRI -\> FOLFOX FOLFOX REGIMEN D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr Every 2 weeks FOLFILI REGIMEN D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr

Drug: irinotecan, oxaliplatin

OXIR arm: FOLFIRI -> FOLFOX

ACTIVE COMPARATOR

OXIR arm: FOLFIRI -\> FOLFOX FOLFOX REGIMEN D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr Every 2 weeks FOLFILI REGIMEN D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr

Drug: oxaliplatin, irinotecan

Interventions

irinotecan, oxaliplatinDRUG

OXIR: FOLFOX -\> FOLFIRI IROX: FOLFIRI -\> FOLFOX FOLFOX REGIMEN D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr Every 2 weeks FOLFILI REGIMEN D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr Every 2 weeks

IROX arm: FOLFIRI -> FOLFOX
oxaliplatin, irinotecanDRUG

FOLFOX REGIMEN D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr Every 2 weeks FOLFILI REGIMEN D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr Every 2 weeks

OXIR arm: FOLFIRI -> FOLFOX

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed gastric cancer
  • No prior chemotherapy for palliative setting
  • ECOG PS \<3
  • Measurable lesion on CT
  • adequate kidney function (CCr ≥ 40 ml/min)
  • adequate liver function (Transaminase \< 3 X upper normal value, Bilirubin \< 2 mg%)
  • adequate BM function (ANC \> 1500/ul, platelet \> 75000/ul)
  • informed consent

You may not qualify if:

  • other cancer history
  • pregnant or breast feeding
  • inadequate general condition for chemotherapy
  • allergy to oxaliplatin or irinotecan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sung Yong Oh

Busan, 602-715, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

IrinotecanOxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCoordination ComplexesOrganic Chemicals

Study Officials

  • HYUK-CHAN KWON, M.D.,Ph.D

    Dong-A University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of internal medicine

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 8, 2010

Study Start

September 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

KR(1)