CompletedPhase 2ACTRN12606000163505

ATTAX

ATTAX: A randomised phase II study evaluating tumour response rates of a weekly schedule of docetaxel with cisplatin and 5-FU (wTCF) or with Capecitabine (wTX) in advanced oesophago-gastric cancer.

Sponsor

Australasian Gastro-Intestinal Trials Group A(AGITG)

Enrollment

100 participants

Start Date

Jun 2, 2006

Study Type

Interventional

Conditions

Locally recurrent or metastatic oesophago-gastric cancer

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying: ATTAX. It may be open to adults aged 18 and older who meet certain criteria, including: Histological diagnosis of metastatic or locally recurrent oesophago. Participation typically involves medical assessments, possible treatment with the study intervention, and follow-up visits to track your health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 consist

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.

Locations(1)

Australia

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ACTRN12606000163505