A randomised phase II study of pre-operative or peri-operative docetaxel, oxaliplatin, capecitabine (DOX) regimen in patients with locally advanced resectable gastric cancer - IRST 151.01

• Conditions: Patient with potentially resectable adenocarcinoma of the stomach; MedDRA version: 14.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-020189-37-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-14
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female 18-75 years of age
• Diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach
• cT3 subserosal - cT4a – cT4b (7th edition UICC TNM) or bulky lymph node metastases independently of T
• ECOG performance status 0-1 at study entry
• Laboratory requirements (up to 8 days prior to randomization):
a) Haematology:
I) Neutrophils > 1.5 x 109 /L
II) Platelets > 100 x 109 /L
III) Hemoglobin > 10g/dL
b) Hepatic function
I) Total bilirubin < 1.25 UNL
II) AST (SGOT) and ALT (SGPT)<2.5xUNL
II) Alkaline phosphatase < 2.5xUNL c) Renal function
I) Creatinine <1.5 UNL
In the presence of border-line values, the calculated creatinine clearance should be >= 60 mL/min;
• Written informed consent signed and dated before randomization procedures, must be obtained and documented according to the local regulatory requirement.
• Effective contraception for both male and female patients if the risk of conception exists.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Early gastric cancer (if N0)
• T2 (according to 7th edition of UICC TNM) if N0
• Linitis plastica
• Positive peritoneal cytology
• Distant metastases
• Tumor involving the gastro-esophageal junction
• Peritoneal involvement
• Concurrent chronic systemic immune therapy
• Any investigational agent(s) 4 weeks prior to study entry
• Clinically relevant coronary artery disease, a history of myocardial infarction or a history of hypertension not controlled by therapy within the last 12 months
• Known grade 3 or 4 allergic reaction to any of the components of the treatment
• Known drug abuse/alcohol abuse
• Legal incapacity or limited legal capacity
• Medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent
• Women who are pregnant or breastfeeding
• Acute or subacute intestinal occlusion
• Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for = 5 years will be allowed to enter the trial)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The percentage of patients receiving all the planned chemotherapeutic cycles.;Secondary Objective: • Downstaging according to Recist criteria • pT1-3 vs pT0. • Safety: number of patients with grade 3-4 toxicity • The role of PET Scan as predictor of response • Curative vs palliative surgery • TTP • OS • Diagnostic correlation between the various staging methods • Possible correlations between CT scan, CT/PET, laparoscopy; • Molecualr marker related to toxicity: DPYD, MTHFR, TS, XPD, ERCC1, XRCC1; • Molecular marker related to prognosis: TYMS, GSTP1, COX-2, RUNX3, methylation profile (Cox2, hMLH1, MGMT); • Molecular marker related to therapy response: TYMS, DPYD, MTHFR, OPRT, ERCC1, XRCC1/2/3, GSTP1, GSTM1, GSTT1, ABCB1, methylation profile (Cox2, hMLH1, MGMT), whole genome arrayCGH;Primary end point(s): The percentage of patients receiving all the planned chemotherapeutic cycles.