None listed
Conditions
Brief summary
Most cases of oesophageal and gastric cancer are locally advanced or metastatic at presentation. Chemotherapy prolongs survival and improves quality of life in such patients, but standard chemotherapy for this disease has not been defined. Doxetaxel is a taxane with promising single agent activity in oesophago-gastric cancer. Combination chemotherapy regimens based on docetaxel may therefore have significant activity with a more favourable toxicity profile. This randomised phase II study explores the activity and toxicity of two novel docetaxel based regimens; weekly docetaxel, cisplatin and infused 5-FU (wTCF) and weekly docetaxel plus capecitabine (wTX) in patients with metastatic oesophago-gastric cancer. Based on the results achieved in this study, the AGITG would aim to test the best regimen in a future phase III study comparing it with ECF or another accepted standard regimen.
Interventions
This study has two treatment arms:
Weekly TCF consisting of Docetaxel 30 mg/m2 d1, d8; Cisplatin 60 mg/m2 d1 and protracted venous infusion fluorouracil (5-FU) 200 mg/m2/d for 21d
Weekly TX consisting of Docetaxel 30 mg/m2 d1, d8; Capecitabine 800 mg/m2 bd orally d1-14.
Each cycle administered 3 weekly for a total of 8 cycles.
Sponsors
Australasian Gastro-Intestinal Trials Group A(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
Histological diagnosis of metastatic or locally recurrent oesophago-gastric cancer (squamous cell, adenocarcinoma or undifferentiated carcinoma)-Any primary oesophago-gastric site (oesophagus, oesophago-gastric junction (OGJ) or stomach)-Unidimensional measurable disease as assessed by CT scan (RECIST criteria)- No prior radiation except for; Adjuvant radiation (radiation alone or chemo-radiation allowed) which must have been completed >12 months ago. For patients who have received adjuvant radiotherapy, the site(s) of measurable disease should include at least one which was not encompassed by the radiation field(s) unless this site has demonstrated clear progression.Palliative radiotherapy provided there was no concurrent chemotherapy administered, all radiation toxicities have resolved to grade 1 or less and at least 14d has elapsed from the last dose of radiotherapy until the start of chemotherapy in ATTAX. For patients who have received palliative radiotherapy, the site(s) of measurable disease should include at least one which was not encompassed by the radiation field(s)-No prior chemotherapy agents, except adjuvant chemotherapy > 12 months ago.
Exclusion criteria
Metastatic disease of the central nervous system.
Outcome results
None listed