Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma
18 Years
N/A
Both
Adenocarcinoma of the Gastroesophageal Junction, Cancer-related Problem/Condition, Esophageal Cancer, Gastric Cancer, Nausea and Vomiting, Pain
Trial Information
Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the esophagus or stomach, including
adenocarcinoma of the esophagogastric junction
- Advanced disease not amenable to curative treatment
- Documented progressive disease while receiving or within 6 months of completion
of first-line chemotherapy with a platinum- and fluoropyrimidine-based therapy
either for advanced disease or as neoadjuvant/perioperative therapy
- No cerebral or leptomeningeal metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Hemoglobin ≥ 10 g/dL
- WBC ≥ 3.0 x 10^9/L
- ANC ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Total bilirubin normal
- ALT ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months
after completion of treatment
- No clinically significant peripheral neuropathy (grade 2-4)
- No prior malignancy except for curatively treated basal cell carcinoma of the skin or
cervical intraepithelial neoplasia
- No medical or psychiatric condition that would influence the ability of patients to
provide informed consent
- No other serious or uncontrolled illness that, in the opinion of the investigator,
makes it undesirable for the patient to enter the trial
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy with taxanes
- ≤ 1 prior chemotherapy regimen in advanced setting allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Hugo Ford, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cambridge University Hospitals NHS Foundation Trust
Authority:
Unspecified
Study ID:
CDR0000649670
NCT ID:
NCT00978549
Start Date:
April 2008
Completion Date:
Related Keywords:
- Adenocarcinoma of the Gastroesophageal Junction
- Cancer-Related Problem/Condition
- Esophageal Cancer
- Gastric Cancer
- Nausea and Vomiting
- Pain
- pain
- nausea and vomiting
- cancer-related problem/condition
- adenocarcinoma of the esophagus
- adenocarcinoma of the stomach
- adenocarcinoma of the gastroesophageal junction
- recurrent esophageal cancer
- stage III esophageal cancer
- stage IV esophageal cancer
- recurrent gastric cancer
- stage III gastric cancer
- stage IV gastric cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Esophageal Diseases
- Esophageal Neoplasms
- Stomach Neoplasms
- Nausea
- Vomiting
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