Trials / Completed
CompletedNCT00978549
Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer
Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Adenocarcinoma of the Gastroesophageal Junction
- Esophageal Cancer
- Gastric Cancer
- Nausea and Vomiting
- Pain
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2010-04-01
- Completion
- 2010-10-01
- First posted
- 2009-09-17
- Last updated
- 2013-08-07
Locations
8 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00978549. Inclusion in this directory is not an endorsement.