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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12609000757213
• Date of registration: 01/09/2009
• Prospective Registration: No
• Primary sponsor: Hellenic Cooperative Oncology Group
• 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.
• Date of first enrolment: 15/04/2002
• Target sample size: 206
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12609000757213.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;
• Phase: Phase 3

Countries of recruitment

Greece

Contacts

• Name: Aristotle Bamias

• Name: Eleni Papakostaki

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

operable gastric cancer;
operable gastric cancer

Cancer - Stomach

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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]

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]

Source(s) of Monetary Support

Hellenic Cooperative Oncology Group