NCT00629863

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 7, 2013

Status Verified

January 1, 2009

Enrollment Period

5 years

First QC Date

March 5, 2008

Last Update Submit

August 6, 2013

Conditions

Esophageal CancerGastric Cancer

Keywords

stage I gastric cancerstage II gastric cancerstage III gastric cancerstage I esophageal cancerstage II esophageal cancerstage III esophageal cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

cisplatinDRUG
fluorouracilDRUG
questionnaire administrationOTHER
diagnostic endoscopic procedurePROCEDURE
neoadjuvant therapyPROCEDURE
quality-of-life assessmentPROCEDURE
therapeutic conventional surgeryPROCEDURE
therapeutic endoscopic surgeryPROCEDURE
ultrasound imagingPROCEDURE
radiation therapyRADIATION
radioisotope therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Royal Blackburn Hospital

Blackburn, England, BB2 3 HH, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

North Tyneside Hospital

North Shields, England, NE29 8NH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

North Wales Organisation for Randomised Trials in Health

Bangor, Wales, LL57 2PZ, United Kingdom

Location

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Interventions

CisplatinFluorouracilNeoadjuvant TherapyHigh-Energy Shock WavesRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCombined Modality TherapyTherapeuticsUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Ken Park, MD

    North Wales Organisation for Randomised Trials in Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 6, 2008

Study Start

September 1, 2004

Primary Completion

September 1, 2009

Study Completion

January 1, 2010

Last Updated

August 7, 2013

Record last verified: 2009-01

Locations

GB(9)