Clinical trial NCT00190476: Elderly NSCLC/D vs DP (JCOG0207)
Official title: Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-small-cell Lung Cancer
Keywords: Elderly
advanced
non-small-cell lung cancer
cisplatin
docetaxel
weekly
combination
chemotherapy
randomized trial
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-09-19
Enrollment: 230
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: overall survival
Secondary outcomes:
measure: Toxicity
measure: Progression-free survival
measure: Response rate
measure: Symptom score
Other outcomes:
Locations:
city: Nagoya,Chikusa-ku,Kanokoden,1-1
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Okazaki,Kake-machi,Kuriyado,18
country: Japan
facility: Aichi Cancer Center,Aichi Hospital
state: Aichi
city: Kashiwa,Kashiwanoha,6-5-1
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama,Horinouchi,13
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Higashi-ku,Maidashi,3-1-1
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Gifu,Kashima-cho,7-1
country: Japan
facility: Gifu Municipal Hospital
state: Gifu
city: Ota,Takabayashi-nishi-cho,617-1
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Shibukawa,Kanai,2854
country: Japan
facility: National Nishigunma Hospital
state: Gunma
city: Asahikawa,Hanasaki,7-4048
country: Japan
facility: National Hospital Organization, Dohoku National Hospital
state: Hokkaido
city: Sapporo,Shiroishi-ku,Kikusui,4-2-3-54
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Akashi,Kitaouji-cho,13-70
country: Japan
facility: Hyogo Medical Center for Adults
state: Hyogo
city: Nishinomiya,Mukogawa-cho,1-1
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Nishi-ibarakigun,Tomobemachi,Koibuchi,6528
country: Japan
facility: Ibaraki Kenritsu Chuo Hospital & Cancer Center
state: Ibaraki
city: Yokohama,Asahi-ku,Nakao,1-1-2
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Yokohama,Hodogaya-ku,Okazawa-cho,56
country: Japan
facility: Yokohama Mucipical Citizen's Hospital
state: Kanagawa
city: Kumamoto,Honjo,5-16-10
country: Japan
facility: Kumamoto Regional Medical Center Hospital
state: Kumamoto
city: Niigata,Kawagishi-cho, 2-15-3
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Habikino,Habikino,3-7-1
country: Japan
facility: Osaka Prefectural Medical Center for Respiratory and Allergic Disease
state: Osaka
city: Osaka,Higashinari-ku,Nakamichi,1-3-3
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka
city: Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Osaka-Sayama,Ohno-higashi,377-2
country: Japan
facility: Kinki University School of Medicine
state: Osaka
city: Sakai,Nagasone,1180
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
state: Osaka
city: Toyonaka,Toneyama,5-1-1
country: Japan
facility: National Hospital Organization Toneyama National Hospital
state: Osaka
city: Kita-adachi,Ina,Komuro,818
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
country: Japan
facility: Sizuoka Cancer Center
state: Shizuoka
city: Utsunomiya,Yohnan,4-9-13
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Chuo-ku,Tsukiji,5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Shinjuku-ku,Toyama,1-21-1
country: Japan
facility: International Medical Center of Japan
state: Tokyo
city: Yamagata,Aoyagi,1800
country: Japan
facility: Yamagata Prefectural Central Hospital
state: Yamagata
Study officials:
affiliation: Department of Internal Medicine, Niigata Cancer Center Hospital
name: Akira Yokoyama, MD, PhD
role: STUDY_CHAIR
References:
citation: Tsukada H, Yokoyama A, Goto K, Shinkai T, Harada M, Ando M, Shibata T, Ohe Y, Tamura T, Saijo N; Lung Cancer Study Group of the Japan Clinical Oncology Group (JCOG). Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer: Japan Clinical Oncology Group (JCOG) 0207dagger. Jpn J Clin Oncol. 2015 Jan;45(1):88-95. doi: 10.1093/jjco/hyu176. Epub 2014 Nov 6.