Effect of Chemotherapy Given Either by Mouth or by Infusion on the Quality of Life of Patients With Recurrent Ovarian Epithelial Cancer

NCT ID: NCT00004909

Last Updated: 2011-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-11-30

Study Completion Date

2002-11-30

Brief Summary

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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.

Detailed Description

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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 Patients are withdrawn from study if treatment regimen is changed from oral to IV, or from IV to oral during this 6 months.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.

Conditions

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Ovarian Cancer Malignant Tumor of Peritoneum Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Oral chemotherapy

No interventions assigned to this group

Parenteral chemotherapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Northwestern University

Principal Investigators

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Elizabeth Calhoun, PhD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

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Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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NU-98Q3

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1694

Identifier Type: -

Identifier Source: secondary_id

NU 98Q3

Identifier Type: -

Identifier Source: org_study_id

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