Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Capecitabine; Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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