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

December 17, 2013 updated by: National Hospital Organization Kinki-chuo Chest Medical Center

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)"

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Hospital Organization Kinki-chuo Chest Medical Center

Investigators

  • Study Chair: Masaaki Kawahara, MD, National Hospital Organization Osaka National Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Registration Dates

First Submitted

October 20, 2005

First Submitted That Met QC Criteria

October 20, 2005

First Posted (Estimate)

October 21, 2005

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000450163
  • NHOK-BRI-LC03-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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