Elderly NSCLC/D vs DP (JCOG0207)

This study has been terminated.
Sponsor:
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
  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
Detailed 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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014