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NCT00190476 Clinical Trial

Elderly NSCLC/D vs DP (JCOG0207)

Non-small-cell Lung Cancer Clinical Trial

Official title:
Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00190476
Other study ID # JCOG0207
Secondary ID C000000146
Status Terminated
Phase Phase 3
First received September 11, 2005
Last updated September 8, 2016
Start date April 2003
Est. completion date April 2007

Study information
Verified date September 2016
Source Japan Clinical Oncology Group
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

Description:

The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination.

Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.

Recruitment information / eligibility
Status Terminated
Enrollment 230
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility Inclusion Criteria:

1. histologically or cytologically proven non-small-cell lung cancer

2. stage IV, or stage III disease ineligible for definitive radiotherapy

3. 70 years or older

4. ECOG PS 0-1

5. Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy

6. No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms

7. No prior surgery within 4 weeks before enrollment

8. No prior radiotherapy for primary tumor

9. No prior radiotherapy for metastatic lesions within 2 weeks before enrollment

10. Adequate organ function

11. Signed informed consent

Exclusion Criteria:

1. Symptomatic brain metastasis

2. Active another neoplasms

3. Severe SVC syndrome

4. Massive pericardial, pleural effusion, or ascites

5. Bone metastasis emergent for palliative radiotherapy or surgery

6. Uncontrollable systemic hypertension

7. Heart failure, Unstable angina, Myocardial infarction within 6 months

8. Uncontrollable diabetes

9. Active infection

10. Interstitial pneumonia/ Pulmonary fibrosis

11. Hypersensitivity for polysorbate 80

12. Systemic administration of corticosteroids

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Weekly docetaxel alone

• Weekly docetaxel + cisplatin combination

Locations
Country Name City State
Japan Hyogo Medical Center for Adults Akashi,Kitaouji-cho,13-70 Hyogo
Japan National Hospital Organization, Dohoku National Hospital Asahikawa,Hanasaki,7-4048 Hokkaido
Japan National Cancer Center Hospital Chuo-ku,Tsukiji,5-1-1 Tokyo
Japan Gifu Municipal Hospital Gifu,Kashima-cho,7-1 Gifu
Japan Osaka Prefectural Medical Center for Respiratory and Allergic Disease Habikino,Habikino,3-7-1 Osaka
Japan Kyushu University Hospital Higashi-ku,Maidashi,3-1-1 Fukuoka
Japan National Cancer Center Hospital East Kashiwa,Kashiwanoha,6-5-1 Chiba
Japan Saitama Cancer Center Kita-adachi,Ina,Komuro,818 Saitama
Japan Kumamoto Regional Medical Center Hospital Kumamoto,Honjo,5-16-10 Kumamoto
Japan National Hospital Organization Shikoku Cancer Center Matsuyama,Horinouchi,13 Ehime
Japan Aichi Cancer Center Hospital Nagoya,Chikusa-ku,Kanokoden,1-1 Aichi
Japan Niigata Cancer Center Hospital Niigata,Kawagishi-cho, 2-15-3 Niigata
Japan Ibaraki Kenritsu Chuo Hospital & Cancer Center Nishi-ibarakigun,Tomobemachi,Koibuchi,6528 Ibaraki
Japan Hyogo College of Medicine Nishinomiya,Mukogawa-cho,1-1 Hyogo
Japan Aichi Cancer Center,Aichi Hospital Okazaki,Kake-machi,Kuriyado,18 Aichi
Japan Osaka Medical Center for Cancer and Cardiovascular Diseases Osaka,Higashinari-ku,Nakamichi,1-3-3 Osaka
Japan Osaka City General Hospital Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22 Osaka
Japan Kinki University School of Medicine Osaka-Sayama,Ohno-higashi,377-2 Osaka
Japan Gunma Prefectural Cancer Center Ota,Takabayashi-nishi-cho,617-1 Gunma
Japan National Hospital Organization Kinki-Chuo Chest Medical Center Sakai,Nagasone,1180 Osaka
Japan National Hospital Organization Hokkaido Cancer Center Sapporo,Shiroishi-ku,Kikusui,4-2-3-54 Hokkaido
Japan National Nishigunma Hospital Shibukawa,Kanai,2854 Gunma
Japan International Medical Center of Japan Shinjuku-ku,Toyama,1-21-1 Tokyo
Japan Sizuoka Cancer Center Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007 Shizuoka
Japan National Hospital Organization Toneyama National Hospital Toyonaka,Toneyama,5-1-1 Osaka
Japan Tochigi Cancer Center Utsunomiya,Yohnan,4-9-13 Tochigi
Japan Yamagata Prefectural Central Hospital Yamagata,Aoyagi,1800 Yamagata
Japan Kanagawa Cancer Center Yokohama,Asahi-ku,Nakao,1-1-2 Kanagawa
Japan Yokohama Mucipical Citizen's Hospital Yokohama,Hodogaya-ku,Okazawa-cho,56 Kanagawa

Sponsors (2)
Lead Sponsor Collaborator
Japan Clinical Oncology Group Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall survival
Secondary Toxicity
Secondary Progression-free survival
Secondary Response rate
Secondary Symptom score
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