Pain Clinical Trial
Official title:
Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma
RATIONALE: Analgesics, antiemetics, steroids, and radiation therapy are effective in helping
to control symptoms caused by cancer. It is not yet known whether these treatments are more
effective when given with or without docetaxel in treating patients with relapsed esophageal
cancer or stomach cancer.
PURPOSE: This randomized phase II trial is studying symptom control given together with
docetaxel to see how well it works compared with symptom control given without docetaxel in
treating patients with relapsed esophageal cancer or stomach cancer.
OBJECTIVES:
Primary
- To compare overall survival of patients with relapsed adenocarcinoma of the esophagus
or stomach after treatment with docetaxel and active symptom control vs active symptom
control alone.
Secondary
- To determine the time to documented progression in patients treated with docetaxel.
- To assess response rates to docetaxel in patients treated with docetaxel.
- To determine toxicity of docetaxel in patients treated with docetaxel.
- To assess the quality of life of these patients.
- To evaluate the health economic impact.
OUTLINE: This is a multicenter study.
Patients are stratified according to stage (locally advanced vs metastatic), site of disease
(esophagus vs esophagogastric junction vs stomach), duration of response to prior
chemotherapy (no response vs response duration < 3 months vs response duration 3-6 months),
and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1 and active symptom control
(e.g., analgesics [including opioids], antiemetics, steroids, palliative radiotherapy)
daily.
- Arm II: Patients receive active symptom control as in arm I. Courses repeat every 3
weeks for up to 6 courses in the absence of disease progression or unacceptable
toxicity.
Patients in arm I undergo tissue biopsy collection at baseline and after 3 courses of
treatment for biomarker analysis.
Quality of life is assessed by the QLQ-C30 and QLQ-STO22 questionnaires at baseline and at
3, 6, 9, 12, 18, and 24 weeks. Health resource use is assessed by the EQ-5D questionnaire at
baseline and then periodically during and after treatment.
After completion of study treatment, patients are followed up every 6 weeks for 1 year and
then every 3 months thereafter.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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