Esophageal CancerNCT00629863
Endoscopic Ultrasound in Diagnosing Cancer in Patients With Localized Stomach Cancer or Esophageal Cancer
A study testing cisplatin, fluorouracil and questionnaire administration in people with Esophageal Cancer and Gastric Cancer, run by North Wales Organisation for Randomised Trials in Health at 9 sites in United Kingdom.
Trial summary
RATIONALE: Diagnostic procedures, such as endoscopic ultrasound, may help doctors learn the extent of stomach cancer or esophageal cancer. PURPOSE: This randomized clinical trial is studying how well endoscopic ultrasound works in diagnosing cancer in patients with localized stomach cancer or esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- cisplatin, fluorouracil and questionnaire administration
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Sep 2004to Jan 2010
- Phase
- Interventional
- 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:
- Diagnosis of gastric or esophageal cancer
- Localized disease
- No metastatic disease
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- American Society of Anesthesiologists grade 1 (no physiological disturbance) or 2 (minor well-compensated physiological impairment)
- Must be fit for surgery and chemotherapy
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
North Wales Organisation for Randomised Trials in Health
Bangor, Wales, LL57 2PZ
Royal Blackburn Hospital
Blackburn, England, BB2 3 HH
Ninewells Hospital
Dundee, Scotland, DD1 9SY
Royal Infirmary - Castle
Glasgow, Scotland, G4 0SF
Gloucestershire Royal Hospital
Gloucester, England, GL1 3NN
Leicester Royal Infirmary
Leicester, England, LE1 5WW
North Tyneside Hospital
North Shields, England, NE29 8NH
Southampton General Hospital
Southampton, England, SO16 6YD
About this study
Official title: Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography COGNATE
RATIONALE: Diagnostic procedures, such as endoscopic ultrasound, may help doctors learn the extent of stomach cancer or esophageal cancer.
PURPOSE: This randomized clinical trial is studying how well endoscopic ultrasound works in diagnosing cancer in patients with localized stomach cancer or esophageal cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the additional effect of endoscopic ultrasound (EUS) staging compared with a standard staging algorithm on the selection of treatment in patients with gastric or esophageal cancer (GOC), including the numbers of patients treated surgically, with multimodality therapy, or with non-surgical means.
- To estimate the effect of EUS staging on the outcome of care of these patients.
- To assess the cost-effectiveness of EUS by comparing improvements in patient outcomes with the additional costs of the procedure.
- To estimate the proportion of patients with GOC who will benefit from EUS and therefore to determine the need for EUS facilities within a population.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor location (gastric vs esophageal vs gastroesophageal junction) and participating center.
All patients undergo standard staging methods. Patients with localized tumors are randomized to undergo either endoscopic ultrasound (EUS) or no further staging. Both groups receive treatment as follows, depending on the type of tumor:
- Mucosal tumors: Patients undergo endoscopic mucosal resection and argon-beam ablation of the surrounding mucosa.
- Resectable tumors: Patients undergo surgery and neoadjuvant chemotherapy comprising cisplatin and fluorouracil.
- Advanced localized disease without the possibility of complete resection: Patients receive chemoradiotherapy or chemotherapy alone depending upon the site. Patients with gastric cancer may undergo palliative surgery.
Quality of life is assessed at 1, 3, 6, 12, 18, and 24 months using questionnaires, including the EuroQol EQ-5D, the EORTC core module QLQ-C30, the EORTC esophageal module QLQ-OES24, and the EORTC gastric module QLQ-STO22.
After completion of study treatment, patients are followed every 3 months for a minimum of 1 year.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- cisplatin, fluorouracil, questionnaire administration, diagnostic endoscopic procedure, neoadjuvant therapy
- Keywords
- stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
fluorouracilDrug
questionnaire administrationOther
diagnostic endoscopic procedureProcedure or surgery
neoadjuvant therapyProcedure or surgery
quality-of-life assessmentProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
therapeutic endoscopic surgeryProcedure or surgery
ultrasound imagingProcedure or surgery
radiation therapyRadiation
radioisotope therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized
Secondary outcomes (3)
Complete resection rate
Quality of survival in the different treatments selected on the basis of staging at 1, 3, 6, 12, 18, and 24 months by EuroQol EQ-5D, EORTC core module QLQ-C30, EORTC esophageal module QLQ-OES24, and EORTC gastric module QLQ-STO22
Health resource utilization, including the selection of treatments and subsequent use of health service resources
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startSep 2004
- Primary completionSep 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Wales Organisation for Randomised Trials in Health
- Sponsor type
- University, hospital or other
- Investigators
- Ken Park, MD, Study chair, North Wales Organisation for Randomised Trials in Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629863
- Sponsor's protocol ID
- NWORTH-COGNATE
- Other IDs
- CDR0000584174, ISRCTN01444215, NWORTH-04/MRE10/10
- Status last verified
- Jan 2009
- First submitted
- 5 Mar 2008
- 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
- Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography COGNATE
- ClinicalTrials.gov ID
- NCT00629863
- Acronym / sponsor ID
- NWORTH-COGNATE
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- North Wales Organisation for Randomised Trials in HealthUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 Mar 2008 (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: Diagnostic procedures, such as endoscopic ultrasound, may help doctors learn the extent of stomach cancer or esophageal cancer.
PURPOSE: This randomized clinical trial is studying how well endoscopic ultrasound works in diagnosing cancer in patients with localized stomach cancer or esophageal cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the additional effect of endoscopic ultrasound (EUS) staging compared with a standard staging algorithm on the selection of treatment in patients with gastric or esophageal cancer (GOC), including the numbers of patients treated surgically, with multimodality therapy, or with non-surgical means.
- To estimate the effect of EUS staging on the outcome of care of these patients.
- To assess the cost-effectiveness of EUS by comparing improvements in patient outcomes with the additional costs of the procedure.
- To estimate the proportion of patients with GOC who will benefit from EUS and therefore to determine the need for EUS facilities within a population.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor location (gastric vs esophageal vs gastroesophageal junction) and participating center.
All patients undergo standard staging methods. Patients with localized tumors are randomized to undergo either endoscopic ultrasound (EUS) or no further staging. Both groups receive treatment as follows, depending on the type of tumor:
- Mucosal tumors: Patients undergo endoscopic mucosal resection and argon-beam ablation of the surrounding mucosa.
- Resectable tumors: Patients undergo surgery and neoadjuvant chemotherapy comprising cisplatin and fluorouracil.
- Advanced localized disease without the possibility of complete resection: Patients receive chemoradiotherapy or chemotherapy alone depending upon the site. Patients with gastric cancer may undergo palliative surgery.
Quality of life is assessed at 1, 3, 6, 12, 18, and 24 months using questionnaires, including the EuroQol EQ-5D, the EORTC core module QLQ-C30, the EORTC esophageal module QLQ-OES24, and the EORTC gastric module QLQ-STO22.
After completion of study treatment, patients are followed every 3 months for a minimum of 1 year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
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 |
|---|---|---|
| cisplatin | Drug | – |
| fluorouracil | Drug | – |
| questionnaire administration | Other | – |
| diagnostic endoscopic procedure | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
| therapeutic conventional surgery | Procedure or surgery | – |
| therapeutic endoscopic surgery | Procedure or surgery | – |
| ultrasound imaging | Procedure or surgery | – |
| radiation therapy | Radiation | – |
| radioisotope therapy | Radiation | – |
Primary outcome
Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized
3 secondary outcomes
Complete resection rate
Quality of survival in the different treatments selected on the basis of staging at 1, 3, 6, 12, 18, and 24 months by EuroQol EQ-5D, EORTC core module QLQ-C30, EORTC esophageal module QLQ-OES24, and EORTC gastric module QLQ-STO22
Health resource utilization, including the selection of treatments and subsequent use of health service resources
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.
Ken Park, MD study chair
North Wales Organisation for Randomised Trials in Health
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cisplatin, fluorouracil and questionnaire administration in people with Esophageal Cancer and Gastric Cancer, run by North Wales Organisation for Randomised Trials in Health at 9 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 9 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.
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 at 12 months of patients last randomized and at 48 months of patients first randomized. 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.