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

This study has been withdrawn prior to enrollment.
(Trial was never activated)
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00477867
First received: May 23, 2007
Last updated: June 7, 2013
Last verified: October 2007
  Purpose

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.


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

Study Type: Interventional
Study Design: Primary Purpose: Health Services Research
Official Title: Assessing Economic Outcomes in Women With Stage III Ovarian Cancer Treated With Intravenous Paclitaxel and Cisplatin v. Intravenous Paclitaxel, Intraperitoneal Cisplatin and Intraperitoneal Paclitaxel on GOG #172: A Feasibility Study of Assessing Costs and Medical Resource Use

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Feasibility of collecting data on medical resource utilization and costs incurred in the care of patients with stage III ovarian cancer [ Designated as safety issue: No ]
  • Feasibility of collecting data on resource utilization incurred outside GOG institutions [ Designated as safety issue: No ]
  • Work load required to collect this data, in terms of mean number of hours required to complete medical resource utilization forms [ Designated as safety issue: No ]

Enrollment: 0
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477867

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Martee L. Hensley, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00477867     History of Changes
Other Study ID Numbers: CDR0000078639, GOG-9905
Study First Received: May 23, 2007
Last Updated: June 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage III ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014