NCT00512304

Brief Summary

Post-operative radio-chemotherapy decrease the recurrence risk of gastric cancer(N Engl J Med 2001). However the chemotherapy regimen (5 fluorouracil IV bolus) used was toxic and suboptimal. We propose to evaluate in adjuvant situation an active and well tolerate chemotherapy regimen (FOLFIRI)in patients with metastatic gastric cancer. During the radiotherapy we will use 5 FU continue infusion as previously reported. The global design of adjuvant treatment will be four FOLFIRI courses, radiotherapy (45 Gy)with 5FU IV continue then four FOLFIRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Timeline
Completed

Started Aug 2007

Longer than P75 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

August 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2013

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2013

Enrollment Period

5.3 years

First QC Date

August 6, 2007

Last Update Submit

March 25, 2026

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • feasibility of treatment

    at the end of the treatment

Study Arms (2)

Preoperative chemoradiotherapy

EXPERIMENTAL
Procedure: association chemotherapy and radiochemotherapy

Postoperative chemoradiotherapy

EXPERIMENTAL
Procedure: association chemotherapy and radiochemotherapy

Interventions

association chemotherapy and radiochemotherapyPROCEDURE
Postoperative chemoradiotherapyPreoperative chemoradiotherapy

Eligibility Criteria

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

You may qualify if:

  • gastric adenocarcinoma histologically confirmed
  • tumor T3 or N+ at the pretherapeutic staging (Scanner and endoscopic ultrasound)
  • performance status WHO\<2
  • serum albumin \>30 gr/l
  • weight loss \< 10% in the next 6 months
  • signed informed consent form

You may not qualify if:

  • metastatic disease
  • prior abdominal radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • MICHEL Pierre, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 7, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2012

Study Completion

October 31, 2013

Last Updated

March 27, 2026

Record last verified: 2013-03

Locations

FR(1)