Status:
COMPLETED
Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will determine the feasibility of adjuvant chemotherapy and chemo-radiotherapy for patients with surgically resected adenocarcinoma of the stomach and gastro-esophageal junction.
Detailed Description
Patients with localized gastric cancer often relapse either locally or systemically. A strategy to reduce relapses at common sites would be beneficial. Our prior trial has proved the feasibility of ad...
Eligibility Criteria
Inclusion
- Patients with radically resected adenocarcinoma of the stomach and/or gastroesophageal junction with histologic proof of adenocarcinoma, pathologically staged T2-3, any N, M0
- No prior radiation therapy to the stomach or immunotherapy or chemotherapy for any reason
- Patients must have a life expectancy of at least 16 weeks and a performance status of \< 2 ECOG scale
- Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study.
- Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of \> 2.000/µL, and platelet count of \> 100.000/µL), adequate liver function (bilirubin \< 1,5 mg/dl), and adequate renal function (creatinine \< 1,5 mg/dl
- Patients must be able to understand the nature of this study and give written informed consent
Exclusion
- Patients with T1N0 carcinoma
- Positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed intra-operatively)
- Biopsy proof of lymph node metastases outside the study field such as supraclavicular, mediastinal, or para-aortic nodes
- Evidence of metastatic disease to distant organs
- Patients with cardiac disease graded as New York Heart Association Class III or IV, severe uncontrolled diabetes, hypertension, cerebron-vascular disease, or infection
- Patients with diabetic neuropathy
- Abnormalities of mental status such that either the patient cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements
- Presence of concurrent or previous malignancies in the past 5 years (except for resected squamous or basal cell carcinoma of the skin)
- Pregnant women are excluded from study entry due to the teratogenic effects of the study treatment
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00718913
Start Date
April 1 2008
End Date
September 1 2009
Last Update
May 18 2015
Active Locations (8)
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1
University Hospital of Crete Dept of Medical Oncology
Heraklion, Crete, Greece
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
4
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece