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.

First Received: October 20, 2005 Last Updated: February 6, 2009 History of Changes

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

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Vinorelbine Gemcitabine Docetaxel Vinorelbine tartrate

U.S. FDA Resources

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000450163, NHOK-BRI-LC03-01
Study First Received:	October 20, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00242983 History of Changes
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
Quality of Life
Carboplatin
Recurrence
Carcinoma
Docetaxel
Vinorelbine
Respiratory Tract Diseases
Paclitaxel

Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Adenocarcinoma of Lung
Adenocarcinoma
Gemcitabine
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009