Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00978549|
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer Gastric Cancer Nausea and Vomiting Pain||Drug: docetaxel 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||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Masking:||None (Open Label)|
|Official Title:||Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma|
|Study Start Date :||April 2008|
|Primary Completion Date :||April 2010|
|Study Completion Date :||October 2010|
- Overall survival
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978549
|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|