Lung CancerNCT00242983
Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer
An observational study of Lung Cancer, run by National Hospital Organization Kinki-chuo Chest Medical Center at 21 sites in Japan.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 21 sitesJapan
- Study dates
- Apr 2004to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Japan21 sites
Toyohashi Municipal Hospital
Aichi, 466-8560
Ichinomiyanishi Hospital
Aichi, 491-0201
Asahikawa Medical College
Asahikawa, 078 8510
National Cancer Center Hospital East
Chiba-ken, 277-8577
Shikoku Cancer Center Hospital
Ehime, 790-0007
National Hospital Organization - Nishigunma National Hospital
Gumna, 377-8511
Gunma Cancer Center
Gunma, 373-8550
National Hospital Organization - Dohoku National Hospital
Hokkaido, 070-0901
Junshinkai Tsuna Hospital
Hyōgo, 663-8501
Takarazuka Municipal Hospital
Hyōgo, 665-0827
Fujisawa City Hospital
Kanagawa, 251-8550
National Hospital Organization - Minamikyoto Medical Center
Kyoto, 610-0113
Miyagi Cancer Center
Miyagi, 981-1293
National Hospital Organization - Okayama Medical Center
Okayama, 701-1192
Osaka Kosei Nenkin Hospital
Osaka, 553-0003
Osaka General Medical Center
Osaka, 558-0056
National Hospital Organization - Osaka National Hospital
Osaka, 591-8555
Saitama Cardiovascular and Respiratory Center
Saitama, 360-0105
Tokyo Medical University
Tokyo, 160
Tottori University Hospital
Tottori, 683-8504
Koseiren Takaoka Hospital
Toyama, 933-8555
About this study
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)"
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- quality-of-life assessment
- 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
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- National Hospital Organization Kinki-chuo Chest Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Masaaki Kawahara, MD, Study chair, National Hospital Organization Osaka National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242983
- Sponsor's protocol ID
- CDR0000450163
- Other IDs
- NHOK-BRI-LC03-01
- Status last verified
- Dec 2005
- First submitted
- 20 Oct 2005
- Last updated
- 18 Dec 2013
- Results posted
- No
Publications
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.
PubMed 21849041
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)"
- ClinicalTrials.gov ID
- NCT00242983
- Acronym / sponsor ID
- CDR0000450163
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- National Hospital Organization Kinki-chuo Chest Medical CenterUniversity, hospital or other
- Study start
- Apr 2004
- First posted
- 21 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Derived from this study: PubMed 21849041Kawahara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaaki Kawahara, MD study chair
National Hospital Organization Osaka National Hospital
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by National Hospital Organization Kinki-chuo Chest Medical Center at 21 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00242983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.