None listed
Conditions
Brief summary
Although oesophageal cancer can be surgically removed, the cancer often comes back. A combination of chemotherapy and radiation before surgery might help, but standard treatment hasn’t been defined and new therapies are needed urgently. This study will test a novel combination of chemotherapy and radiation, with and without a new type of antibody treatment. Effectiveness will be assessed by the amount of tumour left at the time of surgery, the length of time before the tumour begins to grow again, and length of life.
Interventions
Intervention Arm: Induction chemotherapy: 2 cycles of 4 weeks of Docetaxel (D), Cisplatin (C), 5-fluorouracil (5FU) and Cetuximab: Docetaxel 35mg/m2 by intravenous drip on days 1, 8 and 15 of every 4 week cycle, Cisplatin 25mg/m2 by intravenous drip on days 1, 8 and15 of every 4 week cycle, 5FU, 150mg/m2/day by continuous infusion from days 1-21 of every 4 week cycle, Cetuximab initial dose 400mg/m2 by intravenous drip on day 1, then 250mg/m2 by intravenous drip on days 1, 8, 15 and 22 of every
Intervention Arm: Induction chemotherapy: 2 cycles of 4 weeks of Docetaxel (D), Cisplatin (C), 5-fluorouracil (5FU) and Cetuximab: Docetaxel 35mg/m2 by intravenous drip on days 1, 8 and 15 of every 4 week cycle, Cisplatin 25mg/m2 by intravenous drip on days 1, 8 and15 of every 4 week cycle, 5FU, 150mg/m2/day by continuous infusion from days 1-21 of every 4 week cycle, Cetuximab initial dose 400mg/m2 by intravenous drip on day 1, then 250mg/m2 by intravenous drip on days 1, 8, 15 and 22 of every 4 week cycle, Chemotherapy break: 1 week prior to chemoradiotherapy, cetuximab given alone at 250mg/m2 by intravenous drip Chemoradiotherapy: 1 cycle of 5 weeks of Docetaxel (D), Cisplatin (C), Radiotherapy (RT) and Cetuximab: Docetaxel 35mg/m2 by intravenous drip on days 1, 8, 15, 22 and 29 of chemoradiotherapy Cisplatin 25mg/m2 by intravenous drip on days 1, 8, 15, 22 and 29 of chemoradiotherapy Radiotherapy 50.4 Gray (28 fractions/5 fractions per week) Cetuximab 250mg/m2 by intravenous drip on days 1, 8, 15, 22 and 29 of chemoradiotherapy Surgery: Following restaging to exclude metastatic disease, surgery will be performed within 4-8 weeks of completion of chemoradiotherapy.
Sponsors
Australasian Gastro-Intestinal Trials Group (AGITG)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adenocarcinoma of the oesophagus or oesophago-gastric junction, suitable for definitive surgical resection. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Exclusion criteria
Distant visceral or nodal metastases. Previous chemotherapy or radiotherapy for oesophageal cancer. Carcinoma of the cervical oesophagus, or tumour predominantly in the stomach.
Outcome results
None listed