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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00242983
First received: October 20, 2005
Last updated: December 17, 2013
Last verified: December 2005
  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

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)"

Resource links provided by NLM:


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
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: NCT00242983

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00242983     History of Changes
Other Study ID Numbers: CDR0000450163, NHOK-BRI-LC03-01
Study First Received: October 20, 2005
Last Updated: December 17, 2013
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Gemcitabine
Vinorelbine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014