Pre-Operative Or Peri-Operative Dox Regimen In Patients With Locally Advanced Resectable Gastric Cancer (GastroDOC)
Gastric Cancer, Locally Advanced Malignant Neoplasm
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Locally, Advanced, Resectable, Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Signed written informed consents
- 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 of 0-1 at study entry
Laboratory requirements (≤ 7 days prior chemotherapy start):
Hematology:
I) Neutrophils > 1.5 x 109 /L II) Platelets > 100 x 109 /L III) Hemoglobin > 10g/dL
- Hepatic function I) Total bilirubin < 1.25 UNL II) AST (SGOT) and ALT (SGPT) < 2.5xUNL III) Alkaline phosphatase < 2.5xUNL
Renal function I) Creatinine <1.5 UNL In the event of border-line values, the calculated creatinine clearance should be > 60 mL/min;
- Written informed consent signed and dated before randomization procedures, including expected cooperation of patients for treatment and follow-up, must be obtained and documented according to local regulatory requirements.
- Effective contraception for both male and female patients if the risk of conception exists
Exclusion Criteria:
- Early gastric cancer (if N0)
- T2 (according to 7th edition of UICC TNM) if N0
- Linitis plastica
- Positive peritoneal cytology
- Distant metastases
- Neoplasm involving the gastro-esophageal junction
- Pertoneal involvement
- Concurrent chronic systemic immune therapy
- Any investigational agent(s) administered 4 weeks prior to entry
- Clinically relevant coronary artery disease, a history of myocardial infarction or 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)
Sites / Locations
- Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - GM Lancisi
- USL 8 Arezzo - Presidio Ospedaliero Zona Casentino - Ospedale di Bibbiena
- USL 8 Arezzo - Ospedale "Santa Maria alla Gruccia"
- UO Oncologia , Spedali Civili di Brescia
- Ospedale Bufalini
- UO oncologia medica IRCCS IRST
- UOC Oncologia , Azienda USL 11
- Ospedale Careggi
- UO ONCOLOGIA , Istituto Europeo di Oncologia
- Istituto Clinico Humanitas
- Azienda Ospedaliera Universitaria Pisana
- UO Oncologia, Fondazione Policlinico San Matteo
- UO Oncologia Medica, PO Rimini, AUSL della Romagna
- UO Oncologia , Casa di Cura Tortorella
- Policlinico Le Scotte
- UO Oncologia, Azienda Ospedaliero Treviglio
- UO Oncologia Medica, azienda Ospedaliera di Varese
- Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia
- Ospedale San Filippo Neri
- Ospedale Borgo Trento
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A
Arm B
DOX 4 cycles - Surgery - Follow-up DOX: Docetaxel 35 mg/m2 day 1 and 8 by one hour infusion; Oxaliplatin 80 mg/m2 day 1 by two hours infusion; Capecitabine 750 mg/m2 x 2 daily for 2 weeks, per OS. Treatment should be administered for 4 cycles before surgery. Each cycle will be repeated every 3 weeks.
DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up DOX: Docetaxel 35 mg/m2 day 1 and 8 by one hour infusion; Oxaliplatin 80 mg/m2 day 1 by two hours infusion; Capecitabine 750 mg/m2 x 2 daily for 2 weeks, per OS. Treatment should be administered for 2 cycles before surgery and for further 2 cycles after surgery, unless progression of disease or unacceptable toxicity occurs, or patient refusal. In these cases patients will go off treatment. Each cycle will be repeated every 3 weeks.