Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer
A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer.
PURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
- Compare, by intention to treat analysis, feasibility and efficacy of 4 courses of docetaxel, cisplatin, and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma.
- Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy, metastasis and survival in this patient population.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to study center, tumor site (affecting the Z-line (cardia carcinoma Siewart II and III) vs rest of the stomach), and nodal status (positive vs negative). Patients are randomized to either preoperative chemotherapy followed by surgery (arm I) or surgery followed by postoperative chemotherapy (arm II).
- Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1, and fluorouracil IV continuously on days 1-14 every 3 weeks. Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery. Otherwise, treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Between 3-5 weeks following day 1 of the last course of chemotherapy, patients undergo gastric resection.
- Arm II: Patients undergo immediate gastric resection. Beginning 3-6 weeks after surgery, patients receive 4 courses of docetaxel, cisplatin, and fluorouracil as in arm I.
Quality of life is assessed before the first and third courses of chemotherapy, before and after surgery, and then at 1, 3, and 6 months.
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Histologically confirmed locally advanced gastric carcinoma that is considered operable
- T3-4, Nx, M0 OR
- Tx, N+, M0
Lymph nodes considered positive by sonography should be at least 2 of the following:
- Round
- Echopoor
- Sharp borders
- At least 0.5 cm
No distant metastases, including peritoneal carcinomatosis
- CT scan and peritoneal lavage mandatory
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- 0-2
Life expectancy:
- Greater than 12 weeks
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- AST or ALT no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Adequate renal function within limits to allow for treatment with cisplatin
Cardiovascular:
- No unstable cardiac disease requiring treatment
- No congestive heart failure or angina pectoris even if medically controlled
- No significant arrhythmias
- No myocardial infarction within past 6 months
- Ejection fraction greater than 50% on cardiac sonography or MUGA scan
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix
- No grade 2 or greater peripheral neuropathy of any origin (e.g., alcohol, diabetic)
- No history of anaphylaxis
- No other serious concurrent illness or medical condition that would preclude study therapy
- No history of significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy for gastric carcinoma
Chemotherapy:
- No other concurrent chemotherapy for gastric carcinoma
Endocrine therapy:
- No concurrent endocrine therapy for gastric carcinoma
Radiotherapy:
- No concurrent radiotherapy for gastric carcinoma
Surgery:
- See Disease Characteristics
Other:
- At least 30 days since prior treatment in a clinical trial
- No other concurrent experimental drugs
- No other concurrent anticancer therapy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Taxotere-Cisplatin-5FU preoperatively
TCF preoperatively
|
Preoperatively
|
|
Comparateur actif: Immediate surgery followed by TCF
Surgery followed by Taxotere-Cisplatin-5FU
|
Immediate surgery followed by Taxotere-Cisplatin-5FU
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
|---|
|
Survie sans événement
|
Mesures de résultats secondaires
Mesure des résultats |
|---|
|
La survie globale
|
|
Délai jusqu'à l'échec du traitement mesuré après la fin du traitement à l'étude
|
|
Toxicity measured after completion of study treatment
|
|
Rate of complete resection (RO) and postoperative mortality as measured after surgery
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Rudolf Morant, MD, Tumor Zentrum ZeTup St. Gallen und Chur
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies de l'estomac
- Tumeurs de l'estomac
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Docétaxel
- Cisplatine
Autres numéros d'identification d'étude
- SAKK 43/99
- SWS-SAKK-43/99 (Autre identifiant: SAKK)
- EU-99042
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