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Assessing Quality of Life of Patients With Stomach Cancer
This study is ongoing, but not recruiting participants.
First Received: July 11, 2001   Last Updated: October 13, 2009   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020826
  Purpose

RATIONALE: Assessing quality of life in patients who are undergoing cancer treatment may help determine the effect of treatment on these patients.

PURPOSE: Clinical trial to study the effectiveness of a quality of life assessment in patients who are receiving treatment for stomach cancer.


Condition Intervention
Gastric Cancer
Procedure: quality-of-life assessment

Study Type: Observational
Official Title: An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (The QLQ-STO22) In Assessing The Quality Of Life Of Patients With Gastric Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2001
Detailed Description:

OBJECTIVES:

  • Determine the scale structure, reliability, and validity of the tumor-specific questionnaire, QLQ-STO22, in assessing the quality of life of patients with gastric cancer.
  • Determine the questionnaire's sensitivity to change in clinical health status in these patients.

OUTLINE: Patients are stratified according to type of treatment (potentially curative vs potentially palliative), disease stage (local and locoregional vs metastatic), Karnofsky performance status (less than 80% vs more than 80%), and initial weight gain (none vs less than 10% of total body weight vs 10% or more of total body weight).

  • Curatively Treated Group: Quality of life is assessed at 4 weeks prior to surgery and 3 months after surgery in patients receiving total or partial gastrectomy with curative intent; at 4 weeks prior to chemotherapy and/or radiotherapy, 4 weeks prior to surgery, and 3 months after surgery in patients receiving neoadjuvant chemotherapy and/or radiotherapy followed by total or partial gastrectomy with curative intent; at 4 weeks prior to chemotherapy and/or radiotherapy and 6 weeks after completion of therapy in patients receiving adjuvant chemotherapy and/or radiotherapy following total or partial gastrectomy; and at 4 weeks prior to therapy and 3 months after completion of therapy in patients receiving endoscopic mucosal resection or laparoscopic wedge resection.
  • Palliatively Treated Group: Quality of life is assessed at 3 weeks prior to palliative therapy and 4 weeks after beginning palliative therapy.

PROJECTED ACCRUAL: Approximately 220 patients (110 per group) will be accrued for this study within 2 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed gastric adenocarcinoma
  • Patients treated with curative intent according to one of the following criteria:

    • Plan to undergo total or partial gastrectomy with curative intent
    • Plan to receive neoadjuvant chemotherapy and/or radiotherapy followed by total or partial gastrectomy with curative intent
    • Prior total or partial gastrectomy with curative intent and currently receiving adjuvant chemotherapy and/or radiotherapy
    • Prior endoscopic mucosal resection or laparoscopic wedge resection of early gastric cancer OR
  • Patients with initial diagnosis of gastric cancer or recurrent disease with plans to receive one of the following therapies with palliative intent:

    • Total or partial gastrectomy or bypass procedure
    • Endoscopic procedure (e.g., stent insertion)
    • Chemotherapy and/or radiotherapy
    • Supportive measures only
  • No concurrent enrollment on other quality of life study that would interfere with this study
  • Not previously enrolled on this study

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Any performance status

Life expectancy:

  • At least 2 months for patients treated with curative intent
  • At least 4 weeks for patients treated with palliative intent

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other concurrent malignancies except basal cell carcinoma of the skin
  • No mental impairment that would preclude completion of questionnaire
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020826

Locations
France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Germany
Universitaetsklinikum Charite
Berlin, Germany, D-10117
University of Marburg
Marburg, Germany, D-35033
Spain
Hospital De Navarra
Pamplona, Spain, 31080
Sweden
Sahlgrenska University Hospital
Gothenburg (Goteborg), Sweden, S-413 45
United Kingdom, England
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
United Kingdom, Scotland
Royal Infirmary
Glasgow, Scotland, United Kingdom, G4 0SF
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Study Chair: Jane Blazeby, MB, CHB, FRCS, BSc, MD University Hospitals Bristol NHS Trust
Study Chair: Thierry Conroy, MD Centre Alexis Vautrin
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068717, EORTC-15001, EORTC-40003
Study First Received: July 11, 2001
Last Updated: October 13, 2009
ClinicalTrials.gov Identifier: NCT00020826     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Neoplasms
Stomach Diseases
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009