Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-10-31

Brief Summary

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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

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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

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Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer Gastric Cancer Nausea and Vomiting Pain

Keywords

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pain nausea and vomiting adenocarcinoma of the esophagus adenocarcinoma of the stomach adenocarcinoma of the gastroesophageal junction recurrent gastric cancer stage IIIA gastric cancer stage IIIB gastric cancer stage IIIC gastric cancer stage IV gastric cancer recurrent esophageal cancer stage IIIA esophageal cancer stage IIIB esophageal cancer stage IIIC esophageal cancer stage IV esophageal cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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docetaxel

Intervention Type DRUG

steroid therapy

Intervention Type DRUG

questionnaire administration

Intervention Type OTHER

nausea and vomiting therapy

Intervention Type PROCEDURE

pain therapy

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

standard follow-up care

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Hugo Ford, MD

Role: PRINCIPAL_INVESTIGATOR

Cambridge University Hospitals NHS Foundation Trust

Locations

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Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

Site Status

Addenbrooke's Hospital

Cambridge, England, United Kingdom

Site Status

Warwick Medical School Clinical Trials Unit

Coventry, England, United Kingdom

Site Status

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, United Kingdom

Site Status

Medical Research Council Clinical Trials Unit

London, England, United Kingdom

Site Status

Royal South Hants Hospital

Southampton, England, United Kingdom

Site Status

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom

Site Status

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, United Kingdom

Site Status

Countries

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United Kingdom