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

Lung Cancer Clinical Trial

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)"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00242983
• Other study ID #: CDR0000450163
• Secondary ID: NHOK-BRI-LC03-01
• Status: Active, not recruiting
• Phase: N/A
• First received: October 20, 2005
• Last updated: December 17, 2013
• Start date: April 2004

Study information

• Verified date: December 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
Japan	Ichinomiyanishi Hospital	Aichi
Japan	Toyohashi Municipal Hospital	Aichi
Japan	Asahikawa Medical College	Asahikawa
Japan	National Cancer Center Hospital East	Chiba-ken
Japan	Shikoku Cancer Center Hospital	Ehime
Japan	National Hospital Organization - Nishigunma National Hospital	Gumna
Japan	Gunma Cancer Center	Gunma
Japan	National Hospital Organization - Dohoku National Hospital	Hokkaido
Japan	Junshinkai Tsuna Hospital	Hyogo
Japan	Takarazuka Municipal Hospital	Hyogo
Japan	Fujisawa City Hospital	Kanagawa
Japan	National Hospital Organization - Minamikyoto Medical Center	Kyoto
Japan	Miyagi Cancer Center	Miyagi
Japan	National Hospital Organization - Okayama Medical Center	Okayama
Japan	National Hospital Organization - Osaka National Hospital	Osaka
Japan	Osaka Kosei Nenkin Hospital	Osaka
Japan	Osaka General Medical Center	Osaka-shi
Japan	Saitama Cardiovascular and Respiratory Center	Saitama
Japan	Tokyo Medical University	Tokyo
Japan	Tottori University Hospital	Tottori
Japan	Koseiren Takaoka Hospital	Toyama

Sponsors (1)

Lead Sponsor	Collaborator
National Hospital Organization Kinki-chuo Chest Medical Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal