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Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: National Hospital Organization Kinki-chuo Chest Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00242983
  Purpose

RATIONALE: Studying quality-of-life in patients undergoing cancer treatment may help identify the intermediate and long-term effects of treatment on patients with cancer.

PURPOSE: This clinical trial is studying quality of life in patients who are receiving either vinorelbine, gemcitabine, and docetaxel or paclitaxel and carboplatin for advanced non-small cell lung cancer.


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

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Docetaxel Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine Paclitaxel
U.S. FDA Resources
Study Type: Observational
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)"

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 Measures:
  • Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal

Study Start Date: April 2004
Detailed Description:

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.

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242983

Locations
Japan
Asahikawa Medical College
Asahikawa, Japan, 078 8510
Fujisawa City Hospital
Kanagawa, Japan, 251-8550
Gunma Cancer Center
Gunma, Japan, 373-8550
Ichinomiyanishi Hospital
Aichi, Japan, 491-0201
Junshinkai Tsuna Hospital
Hyogo, Japan, 663-8501
Koseiren Takaoka Hospital
Toyama, Japan, 933-8555
Miyagi Cancer Center
Miyagi, Japan, 981-1293
National Cancer Center Hospital East
Chiba-ken, Japan, 277-8577
National Hospital Organization - Dohoku National Hospital
Hokkaido, Japan, 070-0901
National Hospital Organization - Minamikyoto Medical Center
Kyoto, Japan, 610-0113
Toyohashi Municipal Hospital
Aichi, Japan, 466-8560
National Hospital Organization - Okayama Medical Center
Okayama, Japan, 701-1192
National Hospital Organization - Osaka National Hospital
Osaka, Japan, 591-8555
Osaka General Medical Center
Osaka-shi, Japan, 558-0056
Osaka Kosei Nenkin Hospital
Osaka, Japan, 553-0003
Saitama Cardiovascular and Respiratory Center
Saitama, Japan, 360-0105
Shikoku Cancer Center Hospital
Ehime, Japan, 790-0007
Takarazuka Municipal Hospital
Hyogo, Japan, 665-0827
Tokyo Medical University
Tokyo, Japan, 160
Tottori University Hospital
Tottori, Japan, 683-8504
National Hospital Organization - Nishigunma National Hospital
Gumna, Japan, 377-8511
Sponsors and Collaborators
National Hospital Organization Kinki-chuo Chest Medical Center
Investigators
Study Chair: Masaaki Kawahara, MD National Hospital Organization - Osaka National Hospital
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000450163, NHOK-BRI-LC03-01
Study First Received: October 20, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00242983  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the lung
large cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Quality of Life
Carboplatin
Recurrence
Carcinoma
Docetaxel
Vinorelbine
Adenocarcinoma of lung
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009