Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer
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.
Adenocarcinoma of the Gastroesophageal Junction
Nausea and Vomiting
Drug: steroid therapy
Other: questionnaire administration
Procedure: nausea and vomiting therapy
Procedure: pain therapy
Procedure: quality-of-life assessment
Procedure: standard follow-up care
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma|
- Overall survival [ Designated as safety issue: No ]
- Time to documented progression (arm I) [ Designated as safety issue: No ]
- Response rate (arm I) [ Designated as safety issue: No ]
- Toxicity (arm I) [ Designated as safety issue: Yes ]
- Quality of life as assessed by EORTC QLQ-C30 and -STO22 [ Designated as safety issue: No ]
- Health economic evaluation as assessed by EQ-5D [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Warwick Medical School Clinical Trials Unit|
|Coventry, England, United Kingdom, CV4 7AL|
|St. Luke's Cancer Centre at Royal Surrey County Hospital|
|Guildford, England, United Kingdom, GU2 7XX|
|Medical Research Council Clinical Trials Unit|
|London, England, United Kingdom, NW1 2DA|
|Royal South Hants Hospital|
|Southampton, England, United Kingdom, SO14 0YG|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Velindre Cancer Center at Velindre Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Principal Investigator:||Hugo Ford, MD||Cambridge University Hospitals NHS Foundation Trust|