Adenocarcinoma of the Gastroesophageal JunctionPhase 3NCT00978549
Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer
A Phase 3 study testing docetaxel, steroid therapy and questionnaire administration in people with Adenocarcinoma of the Gastroesophageal Junction and Esophageal Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 8 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer
- What is being tested?
- docetaxel, steroid therapy and questionnaire administration
- Type of treatment
- Surgery or procedure
- How many people
- 320 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Apr 2008to Oct 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Warwick Medical School Clinical Trials Unit
Coventry, England, CV4 7AL
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX
Medical Research Council Clinical Trials Unit
London, England, NW1 2DA
Royal South Hants Hospital
Southampton, England, SO14 0YG
About this study
Official title: Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma
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.
Read the 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
- Being tested
- docetaxel, steroid therapy, questionnaire administration, nausea and vomiting therapy, pain therapy
- Keywords
- 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
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Nausea, Vomiting, Pain, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
steroid therapyDrug
questionnaire administrationOther
nausea and vomiting therapyProcedure or surgery
pain therapyProcedure or surgery
quality-of-life assessmentProcedure or surgery
standard follow-up careProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startApr 2008
- Primary completionApr 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the Gastroesophageal JunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Hugo Ford, MD, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978549
- Sponsor's protocol ID
- CRCA-COUGAR-02
- Other IDs
- CDR0000649670, EudraCT-2006-005046-37, ISRCTN13366390, CRUK/07/013, EU-20969
- Status last verified
- Sep 2009
- First submitted
- 16 Sep 2009
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00978549
- Acronym / sponsor ID
- CRCA-COUGAR-02
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer, Nausea and Vomiting, Pain
- Keywords
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | – |
| steroid therapy | Drug | – |
| questionnaire administration | Other | – |
| nausea and vomiting therapy | Procedure or surgery | – |
| pain therapy | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
| standard follow-up care | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Overall survival
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Ford, MD principal investigator
Cambridge University Hospitals NHS Foundation Trust
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing docetaxel, steroid therapy and questionnaire administration in people with Adenocarcinoma of the Gastroesophageal Junction and Esophageal Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.