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The Impact of Oral Chemotherapy on Quality of Life in Patients With Recurrent Epithelial Ovarian Cancer

18 Years
Not Enrolling
Ovarian Cancer, Malignant Tumor of Peritoneum, Quality of Life

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Trial Information

The Impact of Oral Chemotherapy on Quality of Life in Patients With Recurrent Epithelial Ovarian Cancer

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

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 Patients are withdrawn from study if treatment regimen is changed from oral to IV,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.

Inclusion Criteria

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Principal Investigator

Elizabeth Calhoun, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:

NU 98Q3



Start Date:

November 1999

Completion Date:

November 2002

Related Keywords:

  • Ovarian Cancer
  • Malignant Tumor of Peritoneum
  • Quality of Life
  • recurrent ovarian epithelial cancer
  • peritoneal cavity cancer
  • quality of life
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial



Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611