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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004909 |
RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of the treatment on these patients.
PURPOSE: This clinical trial studies the effects of chemotherapy given by mouth versus chemotherapy given by infusion on quality of life in patients with recurrent ovarian epithelial cancer.
Condition | Intervention |
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Cancer-Related Problem/Condition Ovarian Cancer Peritoneal Cavity Cancer |
Procedure: quality-of-life assessment |
Study Type: | Observational |
Official Title: | The Impact of Oral Chemotherapy on Quality of Life in Patients With Recurrent Epithelial Ovarian Cancer |
Study Start Date: | November 1999 |
OBJECTIVES: I. Determine the impact of oral versus parenteral chemotherapy on quality of life (QOL) in patients with recurrent ovarian epithelial cancer.
II. Evaluate the QOL over time in this patient population. III. Determine the impact of disease symptoms, treatment side effects, performance status, and CA-125 levels on QOL assessment in this patient population.
OUTLINE: Patients receive a baseline quality of life (QOL) assessment, an attitudes/preference survey, and a performance status assessment at the time of diagnosis of recurrent disease. Patients are nonrandomly assigned to treatment with either IV or oral chemotherapy using drugs based on National Comprehensive Cancer Network guidelines, prior treatment history, and patient preference. QOL and performance status assessments are obtained again at 3 and 6 months during treatment. Attitudes/preferences are assessed at 6 months. Patients are withdrawn from study if treatment regimen is changed from oral to IV, or from IV to oral during this 6 months.
PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study over 12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Newly diagnosed recurrent ovarian epithelial cancer or recurrent primary peritoneal cancer as evidenced by new clinical or radiologic detected mass or rising serum CA-125 level No progressive disease with ongoing treatment
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fluent in English Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611-3013 |
Study Chair: | Elizabeth Calhoun, PhD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000067589, NU-98Q3, NCI-G00-1694 |
Study First Received: | March 7, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004909 History of Changes |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer peritoneal cavity cancer quality of life |
Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Quality of Life Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms |
Recurrence Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms |
Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |