Elderly NSCLC/D vs DP (JCOG0207)
This study has been terminated.
Sponsor:
Japan Clinical Oncology Group
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00190476
First received: September 11, 2005
Last updated: May 31, 2007
Last verified: May 2007
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Purpose
To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Cancer |
Drug: Weekly docetaxel alone Drug: Weekly docetaxel + cisplatin combination |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial Comparing Docetaxel-Cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-Small-Cell Lung Cancer(JCOG0207) |
Resource links provided by NLM:
Further study details as provided by Japan Clinical Oncology Group:
Primary Outcome Measures:
- overall survival
Secondary Outcome Measures:
- Toxicity
- Progression-free survival
- Response rate
- Symptom score
| Estimated Enrollment: | 230 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | April 2007 |
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.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- histologically or cytologically proven non-small-cell lung cancer
- stage IV, or stage III disease ineligible for definitive radiotherapy
- 70 years or older
- ECOG PS 0-1
- Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
- No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
- No prior surgery within 4 weeks before enrollment
- No prior radiotherapy for primary tumor
- No prior radiotherapy for metastatic lesions within 2 weeks before enrollment
- Adequate organ function
- Signed informed consent
Exclusion Criteria:
- Symptomatic brain metastasis
- Active another neoplasms
- Severe SVC syndrome
- Massive pericardial, pleural effusion, or ascites
- Bone metastasis emergent for palliative radiotherapy or surgery
- Uncontrollable systemic hypertension
- Heart failure, Unstable angina, Myocardial infarction within 6 months
- Uncontrollable diabetes
- Active infection
- Interstitial pneumonia/ Pulmonary fibrosis
- Hypersensitivity for polysorbate 80
- Systemic administration of corticosteroids
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190476
Locations
| Japan | |
| Aichi Cancer Center Hospital | |
| 1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681 | |
| Aichi Cancer Center,Aichi Hospital | |
| 18,Kuriyado,Kake-machi,Okazaki, Aichi, Japan, 444-0011 | |
| National Cancer Center Hospital East | |
| 6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577 | |
| National Hospital Organization Shikoku Cancer Center | |
| 13,Horinouchi,Matsuyama, Ehime, Japan, 790-0007 | |
| Kyushu University Hospital | |
| 3-1-1,Maidashi,Higashi-ku, Fukuoka, Japan, 812-8582 | |
| Gifu Municipal Hospital | |
| 7-1,Kashima-cho,Gifu, Gifu, Japan, 500-8323 | |
| National Nishigunma Hospital | |
| 2854,Kanai,Shibukawa, Gunma, Japan, 377-8511 | |
| Gunma Prefectural Cancer Center | |
| 617-1,Takabayashi-nishi-cho,Ota, Gunma, Japan, 373-8550 | |
| National Hospital Organization Hokkaido Cancer Center | |
| 4-2-3-54,Kikusui,Shiroishi-ku,Sapporo, Hokkaido, Japan, 003-0804 | |
| National Hospital Organization, Dohoku National Hospital | |
| 7-4048,Hanasaki,Asahikawa, Hokkaido, Japan, 070-8644 | |
| Hyogo College of Medicine | |
| 1-1,Mukogawa-cho,Nishinomiya, Hyogo, Japan, 663-8501 | |
| Hyogo Medical Center for Adults | |
| 13-70,Kitaouji-cho,Akashi, Hyogo, Japan, 673-8558 | |
| Ibaraki Kenritsu Chuo Hospital & Cancer Center | |
| 6528 Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki, Japan, 309-1793 | |
| Kanagawa Cancer Center | |
| 1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815 | |
| Yokohama Mucipical Citizen's Hospital | |
| 56,Okazawa-cho,Hodogaya-ku,Yokohama, Kanagawa, Japan, 240-8555 | |
| Kumamoto Regional Medical Center Hospital | |
| 5-16-10,Honjo,Kumamoto, Kumamoto, Japan, 860-0811 | |
| Niigata Cancer Center Hospital | |
| 2-15-3 Kawagishi-cho, Niigata, Niigata, Japan, 951-8566 | |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | |
| 1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka, Japan, 537-8511 | |
| National Hospital Organization Kinki-Chuo Chest Medical Center | |
| 1180,Nagasone,Sakai, Osaka, Japan, 591-8555 | |
| Osaka City General Hospital | |
| 2-13-22,Miyakojimahondori,Miyakojima-ku,Osaka, Osaka, Japan, 534-0021 | |
| Osaka Prefectural Medical Center for Respiratory and Allergic Disease | |
| 3-7-1,Habikino,Habikino, Osaka, Japan, 583-8588 | |
| Kinki University School of Medicine | |
| 377-2,Ohno-higashi,Osaka-Sayama, Osaka, Japan, 589-8511 | |
| National Hospital Organization Toneyama National Hospital | |
| 5-1-1,Toneyama,Toyonaka, Osaka, Japan, 560-8552 | |
| Saitama Cancer Center | |
| 818,Komuro,Ina,Kita-adachi, Saitama, Japan, 362-0806 | |
| Sizuoka Cancer Center | |
| 1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777 | |
| Tochigi Cancer Center | |
| 4-9-13,Yohnan,Utsunomiya, Tochigi, Japan, 320-0834 | |
| International Medical Center of Japan | |
| 1-21-1,Toyama,Shinjuku-ku, Tokyo, Japan, 162-8655 | |
| National Cancer Center Hospital | |
| 5-1-1,Tsukiji,Chuo-ku, Tokyo, Japan, 104-0045 | |
| Yamagata Prefectural Central Hospital | |
| 1800,Aoyagi,Yamagata, Yamagata, Japan, 990-2292 | |
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
| Study Chair: | Akira Yokoyama, MD, PhD | Department of Internal Medicine, Niigata Cancer Center Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00190476 History of Changes |
| Other Study ID Numbers: | JCOG0207, C000000146 |
| Study First Received: | September 11, 2005 |
| Last Updated: | May 31, 2007 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Japan Clinical Oncology Group:
|
Elderly advanced non-small-cell lung cancer cisplatin docetaxel |
weekly combination chemotherapy randomized trial |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Docetaxel Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013