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Companion Study of Quality in Life in Patients With Advanced Non-Small Cell Lung Cancer Treated With Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin on Protocol JMTO-LC00-03

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Natural history/Epidemiology Closed 18 and over Other NHOK-BRI-LC03-01
NCT00242983

Objectives

Compare the quality of life of patients with advanced non-small cell lung cancer treated with vinorelbine, gemcitabine, and docetaxel vs paclitaxel and carboplatin on protocol JMTO-LC00-03.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed primary non-small cell lung cancer, including any of the following:
- Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) disease
- Newly diagnosed stage IV disease
- Recurrent disease after prior surgery and/or radiotherapy

Any of the following cellular subtypes are allowed:
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Unspecified carcinoma

Enrolled on protocol JMTO-LC00-03

Prior/Concurrent Therapy:

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics

Patient Characteristics:

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Expected Enrollment

A total of 80 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Change in the total score from baseline measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L), FACT-Taxane, and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) questionnaires at 9, 18, and 22 weeks or withdrawal

Secondary Outcome(s)

Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal

Outline

This is a multicenter study. Patients receive treatment on protocol JMTO-LC00-03.

Quality of life is assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L), FACT-Taxane, and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) questionnaires at baseline, weeks 9 and 18, and at the completion of treatment.

Trial Contact Information

Trial Lead Organizations

National Hospital Organization Kinki-chuo Chest Medical Center

Masaaki Kawahara, MD, Protocol chair
Ph: 81-72-252-3021
Email: kawaharam@kch.hosp.go.jp

Related Information

PDQ® clinical trial JMTO-LC00-03

Registry Information

Official Title		Assessment of Quality of Life (QOL) in Patients Registered with "Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients with Advanced Non-Small Cell Lung Cancer (JMTO LC00-03)"

Trial Start Date		2004-04-08

Registered in ClinicalTrials.gov		NCT00242983

Date Submitted to PDQ		2005-09-29

Information Last Verified		2005-12-14

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.