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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000584174 | Registry Identifier | PDQ (Physician Data Query) | |
| ISRCTN01444215 | |||
| NWORTH-04/MRE10/10 |
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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.
OBJECTIVES:
Primary
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| fluorouracil | Drug | |||
| questionnaire administration | Other | |||
| diagnostic endoscopic procedure | Procedure | |||
| neoadjuvant therapy | Procedure | |||
| quality-of-life assessment | Procedure | |||
| therapeutic conventional surgery | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival at 12 months of patients last randomized and at 48 months of patients first randomized |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Diagnosis of gastric or esophageal cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Park, MD | North Wales Organisation for Randomised Trials in Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Blackburn Hospital | Blackburn | England | BB2 3 HH | United Kingdom | ||
| Gloucestershire Royal Hospital |
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| therapeutic endoscopic surgery | Procedure |
| ultrasound imaging | Procedure |
| radiation therapy | Radiation |
| radioisotope therapy | Radiation |
| Health resource utilization, including the selection of treatments and subsequent use of health service resources |
| Gloucester |
| England |
| GL1 3NN |
| United Kingdom |
| Leicester Royal Infirmary | Leicester | England | LE1 5WW | United Kingdom |
| North Tyneside Hospital | North Shields | England | NE29 8NH | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Ninewells Hospital | Dundee | Scotland | DD1 9SY | United Kingdom |
| Royal Infirmary - Castle | Glasgow | Scotland | G4 0SF | United Kingdom |
| North Wales Organisation for Randomised Trials in Health | Bangor | Wales | LL57 2PZ | United Kingdom |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D020360 | Neoadjuvant Therapy |
| D019220 | High-Energy Shock Waves |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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