Esophageal CancerNCT00003321
Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus
An observational study of Esophageal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- psychosocial assessment and care and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 370 participants
- Where
- 10 sitesin 8 countries
- Study dates
- Feb 1998to Aug 2001
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
10 sites in 8 countries.
10 sites in 8 countries
France2 sites
Clinique Armoricaine De Radiologie
Saint Brieux, F-22015
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Germany2 sites
Robert Roessle Klinik
Berlin, D-13122
University of Marburg
Marburg, D-35033
Australia1 site
Sir Charles Gairdner Hospital, Perth
Perth, Western Australia, 6009
Switzerland1 site
Hopital Cantonal Universitaire de Geneva
Geneva, CH-1211
About this study
Official 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
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.
Read the detailed description
OBJECTIVES: I. Test the psychometric, clinical, and cross cultural validity and reliability of the quality-of-life questionnaire EORTC-QLQ-C30 (version 3.0) in conjunction with the esophageal cancer-specific module EORTC QLQ-OES-24 in patients with esophageal cancer.
OUTLINE: This is a multicenter study. Patients are stratified by treatment (potentially curative vs purely palliative). Patients receiving potentially curative treatment are further stratified according to study treatment (esophagectomy alone vs esophagectomy plus adjuvant or neoadjuvant chemo/radiotherapy vs radical radiotherapy with or without chemotherapy). Patients receiving purely palliative treatment are further stratified according to study treatment (intubation/laser/ethanol injection vs palliative chemo/radiotherapy without endoscopic relief of dysphagia). Patients are administered two questionnaires: (1) The EORTC QLQ-C30 (version 3.0) is a 30-item questionnaire about patient ability to function, symptoms related to the cancer and its treatment, overall health and quality of life, and perceived financial impact of the cancer and its treatment. (2) The EORTC QLQ-OES-24 is a 24-item esophageal cancer-specific questionnaire supplementing EORTC QLQ-C30 with information about disease and treatment-related symptoms and side effects, dysphagia, nutrition, and social and emotional effects of esophageal cancer. Both questionnaires are administered once before and once during or after treatment.
PROJECTED ACCRUAL: 370 patients (170 with locoregional disease, 200 with metastatic disease) will be accrued for this study.
- Conditions
- Esophageal Cancer
- Being tested
- psychosocial assessment and care, quality-of-life assessment
- Keywords
- stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2004 (estimated)
- Study startFeb 1998
- Primary completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jane Blazeby, MB, CHB, FRCS, BSc, MD, Study chair, University Hospitals Bristol and Weston NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003321
- Sponsor's protocol ID
- EORTC-15961-40973
- Other IDs
- EORTC-15961/40973
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 1999
- Last updated
- 12 Jun 2013
- Results posted
- No
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.
PubMed 12075740
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00003321
- Acronym / sponsor ID
- EORTC-15961-40973
- Conditions
- Esophageal Cancer
- Keywords
- stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Feb 1998
- Primary completion
- Aug 2001 (actual)
- First posted
- 22 Mar 2004 (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: 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.
Detailed description
OBJECTIVES: I. Test the psychometric, clinical, and cross cultural validity and reliability of the quality-of-life questionnaire EORTC-QLQ-C30 (version 3.0) in conjunction with the esophageal cancer-specific module EORTC QLQ-OES-24 in patients with esophageal cancer.
OUTLINE: This is a multicenter study. Patients are stratified by treatment (potentially curative vs purely palliative). Patients receiving potentially curative treatment are further stratified according to study treatment (esophagectomy alone vs esophagectomy plus adjuvant or neoadjuvant chemo/radiotherapy vs radical radiotherapy with or without chemotherapy). Patients receiving purely palliative treatment are further stratified according to study treatment (intubation/laser/ethanol injection vs palliative chemo/radiotherapy without endoscopic relief of dysphagia). Patients are administered two questionnaires: (1) The EORTC QLQ-C30 (version 3.0) is a 30-item questionnaire about patient ability to function, symptoms related to the cancer and its treatment, overall health and quality of life, and perceived financial impact of the cancer and its treatment. (2) The EORTC QLQ-OES-24 is a 24-item esophageal cancer-specific questionnaire supplementing EORTC QLQ-C30 with information about disease and treatment-related symptoms and side effects, dysphagia, nutrition, and social and emotional effects of esophageal cancer. Both questionnaires are administered once before and once during or after treatment.
PROJECTED ACCRUAL: 370 patients (170 with locoregional disease, 200 with metastatic disease) will be accrued for this study.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 12 Jun 2013.
- Background: PubMed 12075740Conroy 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.
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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.
Jane Blazeby, MB, CHB, FRCS, BSc, MD study chair
University Hospitals Bristol and Weston NHS Foundation Trust
10 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Germany, Australia, Norway, Spain and 3 more countries. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003321, which also lists 1 linked publication.
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 12 Jun 2013.