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Phase III of Gemcitabine Vs TS-1 Vs Gemcitabine Plus TS-1 in Pancreatic Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Active | 20 and over | 01023017
NCT00498225 |
Trial Description
Summary In patients with unresectable advanced pancreatic cancer, non-inferiority of TS-1 monotherapy and superiority of GEM + TS-1 combination therapy to gemcitabine (GEM) will be verified using survival time. Eligibility Criteria Inclusion Criteria: - Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamous carcinoma.
- Advanced unresectable pancreatic (including pancreatic cancer with local progression and recurrent pancreatic cancer).Presence/absence of measurable lesions is not considered. Patients with measurable lesions must undergo diagnostic imaging tests within 28 days before registration.
- Patients with no previous treatment (radiotherapy,chemotherapy etc) for pancreatic cancer, except resection. Intra-operative radiotherapy during resection of pancreatic cancer will be permitted, although registration must occur at least 4 weeks after the radiotherapy. Patients that have undergone preoperative/postoperative adjuvant chemotherapy may be enrolled if relapse is diagnosed beyond week 24 after the final administration (on day 169 when the day following the final day is set as day 1).
- Age: 20 years to 79 years.
- ECOG Performance Status (PS) of 0 or 1.
- Sufficient function of major organs as defined below. (The following criteria are satisfied in laboratory tests conducted within 14 days before registration. Laboratory tests conducted 2 weeks before registration (on the same weekday) will be included.) White blood cell count≥ 3500/mm3 Neutrophil count≥ 2000/mm3 Hemoglobin≥9.0 g/dL Platelet count≥100000/mm3 Total bilirubin≤ 2.0 mg/dL* *≤ 3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice. AST and ALT≤ 150 U/L Serum creatinine≤1.2 mg/dL Creatinine clearance≥50mL/min.** **Measured values will be used if available. Otherwise, values calculated by the Cockcroft-Gault method will be used.Formula for estimation:body weight (kg) x [140 - age (years) / 72 x serum creatinine (mg/dL)] *Estimated value will be multiplied by 0.85 for females.
- Able to take capsules orally.
- No clinically abnormal ECG findings within 28 days (4 weeks)before registration.
- Voluntarily signed the written consent form.
Exclusion Criteria: - Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28 days before enrollment).
- Active infections (e.g. patients with pyrexia of 38°C or greater), excluding viral hepatitis.
- Serious complications (e.g. heart failure, renal failure,hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
- Moderate or severe (requiring drainage) ascites or pleural effusion requiring treatment.
- Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 3 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration.
- Patients under treatment with flucytosine, phenytoin or warfarin potassium.
- Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
- Judged ineligible by physicians for participation in the study from a safety viewpoint.
Trial Contact Information
Trial Lead Organizations/Sponsors Taiho Pharmaceutical Company, Limited TTY Biopharm
| Takuji Okusaka, MD | | Principal Investigator |
Trial Sites
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| Japan |
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Tokyo |
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| | | | | | | | National Cancer Center Hospital |
| | | Takuji Okusaka, MD |
Ph: +81-3-3542-2511 |
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Email:
tokusaka@ncc.go.jp |
| | | Hideki Ueno, MD |
Ph: +81-3-3542-2511 |
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Email:
hiueno@ncc.go.jp |
| | | Takuji Okusaka, MD | Principal Investigator |
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| Taiwan, Province of China |
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No.100, Tzyou 1st Rd., Kaohsiung |
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| | | | Chung-Ho Memorial Hospital, Kaohsiung Medical University |
| | | Sheng-Fung Lin, M.D. |
Ph: (886)-7-3121101 Ext.6109 |
| | | Sheng-Fung Lin, M.D. | Sub-Investigator |
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No.123, Ta-Pei Rd., Niao-Sung Hsiang, Kaohsiung Hsien |
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| | | Chang Gung Memorial Hospital, Kaohsiung |
| | | Kun-Ming Rau, M.D. |
Ph: (886)-7-7317123 Ext.8303 |
| | | Kun-Ming Rau, M.D. | Sub-Investigator |
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No.135, Nanxiao St., Changhua |
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| | | Changhua Christian Hospital |
| | | Cheng-Shyong Chang, M.D. |
Ph: (886)-4-7238595 Ext.7548 |
| | | Cheng-Shyong Chang, M.D. | Sub-Investigator |
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No.138, Sheng Li Road,Tainan |
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| | | National Cheng Kung University Medical Center |
| | | Wu-Chou Su, M.D. |
Ph: (886)-6-2353535 Ext.5401 |
| | | Wu-Chou Su, M.D. | Sub-Investigator |
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No.2, Yuh-Der Rd.,Taichung |
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| | | China Medical University Hospital |
| | | Chang-Fang Chiu, M.D., Ph.D. |
Ph: (886)-4-22052121 Ext.2011 |
| | | Chang-Fang Chiu, M.D., Ph.D. | Sub-Investigator |
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No.201, Sec. 2, Shih-Pai road, Taipei |
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| | | Taipei Veterans General Hospital |
| | | Jin-Hwang Liu, M.D., Ph.D. |
Ph: (886)-2-28712121 Ext.9 |
| | | Jin-Hwang Liu, M.D., Ph.D. | Sub-Investigator |
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No.201, Taikang Village, Liou Ying Township, Tainan |
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| | | Chi Mei Medical Center Liou Ying Campus |
| | | Wen-Tsun Huang, M.D. |
Ph: (886)-6-6226999 Ext.77651 |
| | | Wen-Tsun Huang Huang, M.D. | Sub-Investigator |
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No.5, Fu-Hsing St. Kuei Shan Hsiang, Taoyuan Hsien |
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| | | Chang-Gung Memorial Hospital - Taoyuan |
| | | Jen-Shi Chen, M.D. |
Ph: (886)-3-328-1200 Ext.8426 |
| | | Jen-Shi Chen, M.D. | Sub-Investigator |
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No.7, Chung San South Road, Taipei |
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| | | National Taiwan University Hospital |
| | | Ann-Lii Cheng, M.D., Ph.D. |
Ph: (886)-2-23123456 Ext.67251 |
| | | Ann-Lii Cheng, M.D., Ph.D. | Principal Investigator |
| | | Chiun Hsu, M.D., Ph.D. |
Ph: (886)-2-23123456 Ext.66789 |
| | | Chiun Hsu, M.D., Ph.D. | Sub-Investigator |
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No.901, Chung Hwa Rd., Yong Kang city, Tainan |
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| | | Chi Mei Medical Center |
| | | Wei-Shou Huang, M.D. |
Ph: (886)-6-2812811 Ext.53215 |
| | | Wei-Shou Huang, M.D. | Sub-Investigator |
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No.92, Sec. 2, Zhongshan N. Rd., Taipei |
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| | | Mackay Memorial Hospital |
| | | Ruey-Kuen Hsieh, M.D. |
Ph: (886)-2-25433535 Ext.3454 |
| | | Ruey-Kuen Hsieh, M.D. | Sub-Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00498225
Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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