Adjuvant randomized study with Docetaxel and Carboplatin with or without radiotherapy in patients with operable gastric cancer.

Phase 3

Completed

• Conditions: operable gastric cancer; Cancer - Stomach

• Registration Number: ACTRN12609000757213
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Histologicaly confirmed gastric adenocarcinoma (gastroesophageal junction included).
Radical excision of the tumor: complete resection of (macroscopically) visible tumor, clear resection margins, no evidence of disease in the peritoneum or in other organs. Patients with limited infiltration of adjacent organs (lesser omentum, pancreas, mesocolon) will be eligible for the study provided that the (macroscopically) visible disease has been resected and the resection margins are clear.
Infiltration of at least the serosa [T3 according to American Joint Committee on Cancer (AJCC)] or evidence of infiltrated lymphnodes.
Age > 18 years
Absence of heart failure
Absolute Neutrophil Count (ANC)>1.500, platelets (PLT)>100.000, serum bilirubin within the normal range, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2xN, creatinine clearance >60 ml/min (calculation according to Cockroft Formula is accepted in patients with normal serum creatinine. Otherwise, 24h urine collection or Glomerular filtration rate (GFR) is required).
Performance Status (PS)< 2
Sufficient nutrition: increased body weight compared with the weight prior to gastrectomy or intake of > 1500 kcal

Exclusion Criteria

Previous history of other malignancy except for completely resected basal cell or squamous skin carcinoma.
Previous history of chemotherapy or radiotherapy
Pregnant or lactating women, or patients unwilling to follow adequate contraceptive methods during treatment period.
Any concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psyciatric disorder that would interfere with the subject safety.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)[5-year survival rate]

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS). This outcome is assessed by physical examination, laboratory evaluation of hematology and biochemistry, computed tomography (CT) of thorax and abdomen (every 6 months), bone scan (if indicated), endoscopy (annually)[5-year DFS rate];Toxicity[1 month since the last administration of the drug. Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc];Translational research studies to assess tumor samples for predictive biomarkers.[Research studied will commence following collection of tumor samples for up to 5 years following completion of the study]