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Trial registered on ANZCTR


Registration number
ACTRN12609000757213
Ethics application status
Approved
Date submitted
24/07/2009
Date registered
1/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adjuvant randomized study with Docetaxel and Carboplatin with or without radiotherapy in patients with operable gastric cancer.
Scientific title
A randomised, phase III study of adjuvant platinum/docetaxel with or without radiotherapy in resected locally advanced gastric cancer. Evaluation of prognostic value of molecular markers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
operable gastric cancer 237335 0
Condition category
Condition code
Cancer 239658 239658 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Docetaxel 75 mg/m2 [intravenous infusion (IV)] in 250 cc Normal Saline (N/S) in 1h
Carboplatin AUC 5 (or Cisplatin in a few cases) (IV) in either 500 cc N/S or 5% Dextrose in 1h every 3 weeks for 6 cycles followed by radiotherapy (45Gy) 3-4 weeks after the 3rd cycle of chemotherapy. The remaining 3 cycles of chemotherapy will be administered 4-5 weeks after the end of radiotherapy.
The entire duration of intervention treatment will be 28 weeks.
Intervention code [1] 236998 0
Treatment: Drugs
Comparator / control treatment
Docetaxel 75 mg/m2 [intravenous infusion (IV)] in 250 cc Normal Saline (N/S) in 1h
Carboplatin AUC 5 (or Cisplatin in a few cases) (IV) in either 500 cc N/S or 5% Dextrose (IV) in 1h every 3 weeks for 6 cycles.
The 6 cycles are carried out consecutively and the overall duration of this treatment is 18 weeks.
Control group
Active

Outcomes
Primary outcome [1] 238433 0
Overall Survival (OS)
Timepoint [1] 238433 0
5-year survival rate
Secondary outcome [1] 244934 0
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)
Timepoint [1] 244934 0
5-year DFS rate
Secondary outcome [2] 244982 0
Toxicity
Timepoint [2] 244982 0
1 month since the last administration of the drug. Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc
Secondary outcome [3] 244983 0
Translational research studies to assess tumor samples for predictive biomarkers.
Timepoint [3] 244983 0
Research studied will commence following collection of tumor samples for up to 5 years following completion of the study

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1915 0
Greece
State/province [1] 1915 0

Funding & Sponsors
Funding source category [1] 237383 0
Other Collaborative groups
Name [1] 237383 0
Hellenic Cooperative Oncology Group
Address [1] 237383 0
18, Hatzikostandi str, 11524 Athens
Country [1] 237383 0
Greece
Primary sponsor type
Other Collaborative groups
Name
Hellenic Cooperative Oncology Group
Address
18, Hatzikostandi str, 11524 Athens
Country
Greece
Secondary sponsor category [1] 236883 0
None
Name [1] 236883 0
Address [1] 236883 0
Country [1] 236883 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study compares the efficacy of a docetaxel and platinum adjuvant chemotherapy regimen in patients with high-risk gastric cancer with that of the same chemotherapy plus radiotherapy.

Patients with histologically proven, radically resected gastric cancer, stage > T3 and/or N+ are randomised between 6 cycles of docetaxel with cisplatin (or carboplatin), both at 75 mg/m2 every 3 weeks (arm A) or the same treatment with radiotherapy (arm B) (45 Gy). The prognostic value of epidermal growth factor receptor (EGFR), excision repair cross-complementation group 1 (ERCC1), human epidermal growth factor receptor 2 (HER2), mesenchymal-epithelial transition factor (c-MET/HGFR), Microtubule-associated-protein (MAP-Tau), and phosphatase and tensin homolog (PTEN) expression are also studied using immunohistochemistry on tissue microarrays (TMA).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29951 0
Address 29951 0
Country 29951 0
Phone 29951 0
Fax 29951 0
Email 29951 0
Contact person for public queries
Name 13198 0
Eleni Papakostaki
Address 13198 0
Hellenic Cooperative Oncology Group, 18 Hatzikostandi str, 11524, Athens
Country 13198 0
Greece
Phone 13198 0
+302106912520
Fax 13198 0
+302106912713
Email 13198 0
hecogoff@otenet.gr; e_papakostaki@hecog.ondsl.gr
Contact person for scientific queries
Name 4126 0
Aristotle Bamias
Address 4126 0
Alexandra Hospital, Department of Clinical Therapeutics, 80 Vas. Sofias
Athens 11528
Country 4126 0
Greece
Phone 4126 0
+302103381546
Fax 4126 0
Email 4126 0
abamias@med.uoa.gr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary