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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

feasibility of treatment

Outcome Time Frame:

at the end of the treatment

Safety Issue:

Yes

Principal Investigator

MICHEL Pierre, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Rouen

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2006/097/HP

NCT ID:

NCT00512304

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

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