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

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

ChemIDplus related topics:

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
First Received:	October 20, 2005
Last Updated:	November 16, 2007
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

Adenocarcinoma of lung

Vinorelbine

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

Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	National Hospital Organization Kinki-chuo Chest Medical Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00242983