SVIBOR - Project code: 3-01-391

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Project code: 3-01-391

CHEMOTHERAPY OF GASTRIC CANCER: RANDOMIZED CLINICAL STUDY (PHASE III) FE VS FEP

Main researcher: ROTH, ANTON (41573)

Assistants

POPIJAČ-KLJUČAR, STANKA (91784)
KOLARIĆ, KRSTO (21661)
ŽUPANC, DARKO (119423)
NOLA-SPEVEC, IVANA (900440)

Type of research: developmental
Duration from: 04/01/91. to 12/31/94.

Papers on project (total): 8

Institution name: Središnji institut za tumore i slične bolesti, Zagreb (74)
Department/Institute: Department for Medical Oncology
Address: Ilica 197
City: 10000 - Zagreb, Croatia

Communication: Phone: 385 (0) 01 17-21-11; Fax: 385 (0) 01 17-55-36

Summary: The most frequently used cytostatics in treatment of advanced gastric cancer are: 5-fluo-rouracil,doxorubicin, 4-epi-doxorubicin, mitomycin C, methotrexat, nitrosoureas and more recently cis DDP and etoposid. It has been proved that combination of the cytostatitcs as compared to the single agent obtains higher percentage of the remissions, but has no impact on the patients survival. By randomized clinical study FE vs. FEP (phase III) in patients with advanced gastric cancer will be examined the effect of high doses of 5-fluorouracil ( 1000 mg/m2 in 6 hour infusion) through five days and high doses of 4-epi-doxorubicin ( 120 mg/m2) on the first day of treatment and be compared with antitumors effect of the same combination plus cis DDP ( 30 mg/m2 on days 2. and 4. of treatment ). In this way the study will answer a question whether there is the difference between two used protocols in the number of objective remissions of the disease, complete remissions, survivals and toxic side effects. Patients will be randomized in two groups ( A and B). The group A will be treated with 5-fluorouracil and 4-epi-doxorubucin, while the group B with 5-fluorouracil, 4-epi-doxorubicin and cis DDP.The cycles will be repeated every 4 weeks. The usual criteria for evaluation of treatment results (WHO/UICC) will be used. In all patients before treatment the following examinations will be done: blood tests,ECG, X-ray of lungs and stomach, gastroscopy, ultrasoud of abdomen, histological verification of the disease, and in the case of need computerized tomography. The examinations which will prove the presence of the disease will be repeated through every 2-3 cycles of the treatment, in order to see the effect of the treatment. Eighty to one hundred patients will be included in the study.

Keywords: gastric cancer, metastatic disease, 5-fluorouracil, 4-epido-xorubicin, cis DDP.

Research goals: In the randomozed clinical study (phase III) will be studied the antitumorous efect of high doses of 5-Fluorouracil (1000mg/m2 in6-hour infusion) during five days and high doses of epirubicin (120mg/m2) on day l. in correlation with the same combination ofcytostatics + cis-DDP (30mg/m2 on days 2. and 4.).This study willanswer if the addition of cis-DDP to 5-Fluororacil and epirubicin in creases the antitumor activity in patients with metastatic gastric cancer. This investigation will show if there will be the difference between the two randomized groups of patients in: 1. The number of objectivs remissions of diesease 2. The number of complete remission of disease 3. Survival of patients 4. Toxic side effects of the treatment It could be expected the at a number of objectivs remissions willbe higher in the group of patients treated with the combination of three cytostatics (5-Fluorouracil, epirubicin and cis-DDP), butit is uncertain if the number of complete remissions and patients surviving will be higher. Toxic side effects of the treatment will be probably higher inthe group of patients with three cytostatics. Until now,the treatment results of patients with the metastatic gastric cancer by use of high doses of 5-Fluorouracil and epirubicin in combination with cis-DDP are not published.

Other information about the project.


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Last update: 04/06/96
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