search
Back to results

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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Locations
Japan
Study Type
Observational
Intervention
quality-of-life assessment
Sponsored by
National Hospital Organization Kinki-chuo Chest Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toyohashi Municipal Hospital
  • Ichinomiyanishi Hospital
  • Asahikawa Medical College
  • National Cancer Center Hospital East
  • Shikoku Cancer Center Hospital
  • National Hospital Organization - Nishigunma National Hospital
  • Gunma Cancer Center
  • National Hospital Organization - Dohoku National Hospital
  • Junshinkai Tsuna Hospital
  • Takarazuka Municipal Hospital
  • Fujisawa City Hospital
  • National Hospital Organization - Minamikyoto Medical Center
  • Miyagi Cancer Center
  • National Hospital Organization - Okayama Medical Center
  • Osaka General Medical Center
  • Osaka Kosei Nenkin Hospital
  • National Hospital Organization - Osaka National Hospital
  • Saitama Cardiovascular and Respiratory Center
  • Tokyo Medical University
  • Tottori University Hospital
  • Koseiren Takaoka Hospital

Outcomes

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

Full Information

First Posted
October 20, 2005
Last Updated
December 17, 2013
Sponsor
National Hospital Organization Kinki-chuo Chest Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00242983
Brief Title
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

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Hospital Organization Kinki-chuo Chest Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaaki Kawahara, MD
Organizational Affiliation
National Hospital Organization Osaka National Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Toyohashi Municipal Hospital
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Ichinomiyanishi Hospital
City
Aichi
ZIP/Postal Code
491-0201
Country
Japan
Facility Name
Asahikawa Medical College
City
Asahikawa
ZIP/Postal Code
078 8510
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Chiba-ken
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Shikoku Cancer Center Hospital
City
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
National Hospital Organization - Nishigunma National Hospital
City
Gumna
ZIP/Postal Code
377-8511
Country
Japan
Facility Name
Gunma Cancer Center
City
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
National Hospital Organization - Dohoku National Hospital
City
Hokkaido
ZIP/Postal Code
070-0901
Country
Japan
Facility Name
Junshinkai Tsuna Hospital
City
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Takarazuka Municipal Hospital
City
Hyogo
ZIP/Postal Code
665-0827
Country
Japan
Facility Name
Fujisawa City Hospital
City
Kanagawa
ZIP/Postal Code
251-8550
Country
Japan
Facility Name
National Hospital Organization - Minamikyoto Medical Center
City
Kyoto
ZIP/Postal Code
610-0113
Country
Japan
Facility Name
Miyagi Cancer Center
City
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
National Hospital Organization - Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka-shi
ZIP/Postal Code
558-0056
Country
Japan
Facility Name
Osaka Kosei Nenkin Hospital
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
National Hospital Organization - Osaka National Hospital
City
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Saitama Cardiovascular and Respiratory Center
City
Saitama
ZIP/Postal Code
360-0105
Country
Japan
Facility Name
Tokyo Medical University
City
Tokyo
ZIP/Postal Code
160
Country
Japan
Facility Name
Tottori University Hospital
City
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Koseiren Takaoka Hospital
City
Toyama
ZIP/Postal Code
933-8555
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21849041
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs