Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE)

Gastric Cancer Clinical Trial

— TRACE  

Official title:

Feasibility Study of 2 Parallel Phases II Pre or Postgastrectomy in Patients With Gastric Cancer (FOLFIRI-radiotherapy Plus 5 Fluorouracil-surgery or Surgery-FOLFIRI-radiotherapy Plus 5 Fluorouracil)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512304
• Other study ID #: 2006/097/HP
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2007
• Last updated: March 4, 2013
• Start date: August 2007

Study information

• Verified date: March 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• metastatic disease

• prior abdominal radiotherapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• association chemotherapy and radiochemotherapy

Locations

Country	Name	City	State
France	University hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of treatment		at the end of the treatment	Yes