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

NCT00242983 | Unknown

• 2 other identifiers: CDR0000450163NHOK-BRI-LC03-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 21

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal

Interventions

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Hospital Organization Kinki-chuo Chest Medical Center: lead

Study Sites (21)

Toyohashi Municipal Hospital

Aichi, 466-8560, Japan

Location

Ichinomiyanishi Hospital

Aichi, 491-0201, Japan

Location

Asahikawa Medical College

Asahikawa, 078 8510, Japan

Location

National Cancer Center Hospital East

Chiba-ken, 277-8577, Japan

Location

Shikoku Cancer Center Hospital

Ehime, 790-0007, Japan

Location

National Hospital Organization - Nishigunma National Hospital

Gumna, 377-8511, Japan

Location

Gunma Cancer Center

Gunma, 373-8550, Japan

Location

National Hospital Organization - Dohoku National Hospital

Hokkaido, 070-0901, Japan

Location

Junshinkai Tsuna Hospital

Hyōgo, 663-8501, Japan

Location

Takarazuka Municipal Hospital

Hyōgo, 665-0827, Japan

Location

Fujisawa City Hospital

Kanagawa, 251-8550, Japan

Location

National Hospital Organization - Minamikyoto Medical Center

Kyoto, 610-0113, Japan

Location

Miyagi Cancer Center

Miyagi, 981-1293, Japan

Location

National Hospital Organization - Okayama Medical Center

Okayama, 701-1192, Japan

Location

Osaka Kosei Nenkin Hospital

Osaka, 553-0003, Japan

Location

Osaka General Medical Center

Osaka, 558-0056, Japan

Location

National Hospital Organization - Osaka National Hospital

Osaka, 591-8555, Japan

Location

Saitama Cardiovascular and Respiratory Center

Saitama, 360-0105, Japan

Location

Tokyo Medical University

Tokyo, 160, Japan

Location

Tottori University Hospital

Tottori, 683-8504, Japan

Location

Koseiren Takaoka Hospital

Toyama, 933-8555, Japan

Location

Related Publications (1)

• 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.

  PMID: 21849041 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Masaaki Kawahara, MD

  National Hospital Organization Osaka National Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 21, 2005
• Study Start: April 1, 2004
• Last Updated: December 18, 2013

Record last verified: 2005-12

Locations

JP (21)