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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00003321




Registration number
NCT00003321
Ethics application status
Date submitted
1/11/1999
Date registered
22/03/2004
Date last updated
12/06/2013

Titles & IDs
Public title
Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus
Scientific title
An International Field Study of the Reliability and Validity of the EORTC-QLQ-C30 and a Disease Specific Questionnaire Module (the EORTC OES-24) in Assessing the Quality of Life of Patients With Oesophageal Cancer
Secondary ID [1] 0 0
EORTC-15961/40973
Secondary ID [2] 0 0
EORTC-15961-40973
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Esophageal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - psychosocial assessment and care
Treatment: Surgery - quality-of-life assessment

Treatment: Surgery: psychosocial assessment and care


Treatment: Surgery: quality-of-life assessment
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Group I: Local or locoregional primary esophageal or
esophago-gastric cancer Planned esophagectomy with or without adjuvant or neoadjuvant
chemotherapy and/or radiotherapy OR Planned radical radiotherapy with or without
chemotherapy Prior endoscopic procedure to relieve dysphagia allowed No distant liver or
bone metastasis if undergoing esophagectomy Group II: Metastatic esophageal cancer or local
anastomotic recurrence of esophageal cancer or deemed unsuitable for esophagectomy Prior
palliation by endoscopic or open intubation, laser treatment, tumor necrosis with alcohol
injection or diathermy, or intraluminal radiotherapy allowed Prior palliative radiotherapy
or chemotherapy allowed No cerebral metastases

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy:
Group I: At least 3 months Group II: At least 4 weeks Hematopoietic: Not specified Hepatic:
Not specified Renal: Not specified Other: Mentally fit to complete a questionnaire or
undergo an interview Aware of diagnosis No concurrent second malignancy except basal cell
skin cancer No concurrent participation in other quality-of-life studies

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
Surgery: See Disease Characteristics
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital, Perth - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Saint Brieux
Country [2] 0 0
France
State/province [2] 0 0
Vandoeuvre-les-Nancy
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Germany
State/province [4] 0 0
Marburg
Country [5] 0 0
Norway
State/province [5] 0 0
Bergen
Country [6] 0 0
Spain
State/province [6] 0 0
Pamplona
Country [7] 0 0
Sweden
State/province [7] 0 0
Gothenburg (Goteborg)
Country [8] 0 0
Switzerland
State/province [8] 0 0
Geneva
Country [9] 0 0
United Kingdom
State/province [9] 0 0
England

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Questionnaires that measure quality of life may improve the ability to plan
treatment for patients who have cancer of the esophagus.

PURPOSE: This clinical trial studies quality-of-life assessments of patients with cancer of
the esophagus who are receiving treatment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00003321
Trial related presentations / publications
Conroy T, Etienne PL, Adenis A, Ducreux M, Paillot B, Oliveira J, Seitz JF, Francois E, Van Cutsem E, Wagener DJ, Kohser F, Daamen S, Praet M, Gorlia T, Baron B, Wils J; European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. Vinorelbine and cisplatin in metastatic squamous cell carcinoma of the oesophagus: response, toxicity, quality of life and survival. Ann Oncol. 2002 May;13(5):721-9. doi: 10.1093/annonc/mdf063.
Public notes

Contacts
Principal investigator
Name 0 0
Jane Blazeby, MB, CHB, FRCS, BSc, MD
Address 0 0
University Hospitals Bristol and Weston NHS Foundation Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00003321