Clinical trial NCT00242983: Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer
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)"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-10-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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.

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 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

Primary outcomes:
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 outcomes:
measure: Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Toyohashi Municipal Hospital
city: Aichi
country: Japan
facility: Ichinomiyanishi Hospital
city: Asahikawa
country: Japan
facility: Asahikawa Medical College
city: Chiba-ken
country: Japan
facility: National Cancer Center Hospital East
city: Ehime
country: Japan
facility: Shikoku Cancer Center Hospital
city: Gumna
country: Japan
facility: National Hospital Organization - Nishigunma National Hospital
city: Gunma
country: Japan
facility: Gunma Cancer Center
city: Hokkaido
country: Japan
facility: National Hospital Organization - Dohoku National Hospital
city: Hyogo
country: Japan
facility: Junshinkai Tsuna Hospital
city: Hyogo
country: Japan
facility: Takarazuka Municipal Hospital
city: Kanagawa
country: Japan
facility: Fujisawa City Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization - Minamikyoto Medical Center
city: Miyagi
country: Japan
facility: Miyagi Cancer Center
city: Okayama
country: Japan
facility: National Hospital Organization - Okayama Medical Center
city: Osaka-shi
country: Japan
facility: Osaka General Medical Center
city: Osaka
country: Japan
facility: Osaka Kosei Nenkin Hospital
city: Osaka
country: Japan
facility: National Hospital Organization - Osaka National Hospital
city: Saitama
country: Japan
facility: Saitama Cardiovascular and Respiratory Center
city: Tokyo
country: Japan
facility: Tokyo Medical University
city: Tottori
country: Japan
facility: Tottori University Hospital
city: Toyama
country: Japan
facility: Koseiren Takaoka Hospital
Study officials:
affiliation: National Hospital Organization Osaka National Hospital
name: Masaaki Kawahara, MD
role: STUDY_CHAIR
References:
citation: Kawahara M, Tada H, Tokoro A, Teramukai S, Origasa H, Kubota K, Shinkai T, Fukushima M, Furuse K. Quality-of-life evaluation for advanced non-small-cell lung cancer: a comparison between vinorelbine plus gemcitabine followed by docetaxel versus paclitaxel plus carboplatin regimens in a randomized trial: Japan Multinational Trial Organization LC00-03 (BRI LC03-01). BMC Cancer. 2011 Aug 17;11:356. doi: 10.1186/1471-2407-11-356.