Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Open label, randomised, multicenter, superiority study for efficacy. Patients with histologically proven adenocarcinoma of the stomach or gastroesophageal junction without gross or microscopic evidence of residual disease after surgery with curative intent and fulfilling all the inclusion/exclusion criteria are eligible for this study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research
• Collaborators: Aventis Pharmaceuticals; Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente; Gruppo Oncologico del Nord-Ovest; Gruppo Oncologico Italiano di Ricerca Clinica; Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori; Italian Trial in Medical Oncology; Oncotech; Southern Italy Cooperative Oncology Group
• Treatments: Cisplatin; Docetaxel; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

Criteria

Inclusion Criteria:

• Histologically proven adenocarcinoma of the stomach or gastroesophageal junction without gross or microscopic evidence of residual disease after surgery with curative intent;

• Subtotal or total gastrectomy with at least D1 dissection;

• Gastroesophageal junction adenocarcinoma extending to the stomach with the center lying 2 to 5 cm below the anatomic esophago-gastric junction;

• Patients with nodal involvement (pN+) or patients without nodal involvement (pN0) with pT2b-3-4. It is recommended to examine at least 15 lymph nodes;

• Age between 18 and 75 years;

• ECOG performance status 0-1;

• No previous chemotherapy and/or radiotherapy;

• Complete staging procedures within 3 months prior to randomization;

• Laboratory requirement (within 8 days prior to randomization):

• Haematology (Neutrophils > 2.0 x 109 /L, Platelet > 100 x 109 /L, Hemoglobin > 10g/dL);

• Hepatic function (Total bilirubin < 1 UNL, ASAT (SGOT) and ALAT (SGPT) < 2.5xUNL, Alkaline phosphatase < 2.5xUNL. Patients with ASAT or ALAT > 1.5xUNL associated with alkaline phosphatase > 2.5XUNL are not eligible.)

• Renal function (Creatinine < 1.5 UNL. In presence of borderline values, the calculated creatinine clearance according to Cockroft-Gault formula, 60 ML/min.

• Recovery from acute effects of surgery. The first infusion of study chemotherapy should be administered 3 to 8 weeks after surgery treatment;

• Written informed consent signed and dated before randomization procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirement.

Exclusion Criteria:

• Non-radical surgery as assessed microscopically (no tumor-free margin of resection, positive biopsy of peritoneal suspicious lesions);

• Synchronous metastases, even curatively resected;

• Pregnant or lactating patients; patients with reproductive potential must implement adequate contraceptive measures;

• Prior or concurrent history of:

• positive HIV serology,

• chronic diarrhoea,

• chronic bowel inflammation or subobstruction,

• neoplasm other than gastric cancer, except for: curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix,

• previous history of myocardial infarction within 1 year from study entry,

• hypersensitivity reaction to polysorbate 80;

• Presence of other systemic disease limiting drug administration and influencing patient survival:

• uncontrolled hypertension,

• high-risk uncontrolled arrhythmia,

• unstable angina pectoris;

• Symptomatic

• peripheral neuropathy,

• altered hearing > 2 grade by NCIC-CTG criteria;

• Active uncontrolled infection.

• Definite contra-indications for the use of corticosteroids: unstable diabetes mellitus, active peptic ulcer;

• Concurrent administration of:

• corticosteroids or equivalent except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions or unless chronic treatment (initiated > 6 months prior to study entry) at low doses (< 20mg methylprednisolone or equivalent);

• any other experimental drug under investigation: concurrent treatment with any other anticancer therapy, growth factors with preventive intent