Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer
| 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
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 Lead Organizations
National Hospital Organization Kinki-chuo Chest Medical Center
 | | | ||
| Masaaki Kawahara, MD, Protocol chair | |
| ||
| ||||
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.
Back to Top
