Status:
COMPLETED
Pre-Operative Or Peri-Operative Dox Regimen In Patients With Locally Advanced Resectable Gastric Cancer
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
Gastric Cancer
Locally Advanced Malignant Neoplasm
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Study design: Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up Population: Male or female, 18-75...
Detailed Description
Title: A randomised phase II study of pre-operative or peri-operative docetaxel, oxaliplatin, capecitabine (DOX) regimen in patients with locally advanced resectable gastric cancer. Clinical Phase: I...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01876927
Start Date
September 1 2010
End Date
September 15 2022
Last Update
January 9 2025
Active Locations (20)
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1
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - GM Lancisi
Ancona, AN, Italy
2
USL 8 Arezzo - Presidio Ospedaliero Zona Casentino - Ospedale di Bibbiena
Bibbiena, AR, Italy
3
USL 8 Arezzo - Ospedale "Santa Maria alla Gruccia"
Montevarchi, AR, Italy
4
UO Oncologia , Spedali Civili di Brescia
Brescia, BS, Italy, 25123