Economic Outcomes in Patients With Stage III Ovarian Cancer Receiving Paclitaxel and Cisplatin on Clinical Trial GOG-172

NCT ID: NCT00477867

Last Updated: 2013-06-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Gathering information about patients with ovarian cancer over time may help doctors learn more about a patient's use of medical services and the cost of these services.

PURPOSE: This clinical trial is collecting information about the patient's health and use of medical resources over time in patients with stage III ovarian cancer receiving paclitaxel and cisplatin on clinical trial GOG-172.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES:

* Determine the feasibility of collecting data on medical resource utilization and costs incurred in the care of patients with stage III ovarian cancer treated with intravenous (IV) paclitaxel and cisplatin vs IV paclitaxel, intraperitoneal (IP) paclitaxel, and IP cisplatin on a randomized, controlled clinical trial.
* Determine the feasibility of collecting data on resource utilization incurred outside GOG institutions through the use of patient diaries.
* Assess the work load required to collect this data, in terms of mean number of hours required to complete medical resource utilization forms.

OUTLINE: Data on medical resource units consumed (including length of hospital stay, length of time using operating room, units of drugs and blood products administered, number of diagnostic tests received, and number of physician visits needed) are collected on all patients.

Quality of life is assessed prior to randomization on clinical trial GOG-172, prior to the fourth course of chemotherapy, after the sixth course of chemotherapy, and at 3 months and 6 months after the sixth course of chemotherapy. Patients complete diaries throughout treatment with chemotherapy and for 12 months after treatment.

Data collected are used for analysis of economic impact, quality of life, neurotoxicity, and sociologic characteristics associated with these treatment regimens.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of stage III ovarian cancer
* Concurrent enrollment on clinical trial GOG-172 required

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* GOG 0-3

Life expectancy:

* Not specified

Other:

* Able to communicate in English or Spanish

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martee L. Hensley, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GOG-9905

Identifier Type: -

Identifier Source: secondary_id

CDR0000078639

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.