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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000757213

Enrollment

206

Registered

2009-09-01

Start date

2002-04-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results