Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer
- Conditions
- Adenocarcinoma of the Gastroesophageal JunctionEsophageal CancerGastric CancerNausea and VomitingPain
- Registration Number
- NCT00978549
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Time to documented progression (arm I) Response rate (arm I) Toxicity (arm I) Quality of life as assessed by EORTC QLQ-C30 and -STO22 Health economic evaluation as assessed by EQ-5D
Trial Locations
- Locations (8)
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Medical Research Council Clinical Trials Unit
🇬🇧London, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Warwick Medical School Clinical Trials Unit
🇬🇧Coventry, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Royal South Hants Hospital
🇬🇧Southampton, England, United Kingdom