Phase III of Gemcitabine Vs TS-1 Vs Gemcitabine Plus TS-1 in Pancreatic Cancer
NCT ID: NCT00498225
Last Updated: 2012-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
834 participants
INTERVENTIONAL
2007-07-31
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Gemcitabine plus TS-1
Gemcitabine plus TS-1
Gemcitabine plus TS-1:Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8 followed by 2 week rest as 1 course. TS-1 was co-administered orally at 40 mg/m2 twice daily for 14 days with a rest period of 1 week as one course.
2
TS-1
TS-1
TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 2week as one course.
3
Gemcitabine
Gemcitabine
Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8, 15 followed by 2 week rest as 1 course.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gemcitabine plus TS-1
Gemcitabine plus TS-1:Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8 followed by 2 week rest as 1 course. TS-1 was co-administered orally at 40 mg/m2 twice daily for 14 days with a rest period of 1 week as one course.
TS-1
TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 2week as one course.
Gemcitabine
Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8, 15 followed by 2 week rest as 1 course.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Watery diarrhoea.
* 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.
* Metastasis in the CNS.
* 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.
* Severe mental disorder.
* Judged ineligible by physicians for participation in the study from a safety viewpoint.
20 Years
79 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TTY Biopharm
INDUSTRY
Taiho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Takuji Okusaka, MD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Cancer Center Hospital
Tokyo, , Japan
Chung-Ho Memorial Hospital, Kaohsiung Medical University
No.100, Tzyou 1st Rd., Kaohsiung, , Taiwan
Chang Gung Memorial Hospital, Kaohsiung
No.123, Ta-Pei Rd., Niao-Sung Hsiang, Kaohsiung Hsien, , Taiwan
Changhua Christian Hospital
No.135, Nanxiao St., Changhua, , Taiwan
National Cheng Kung University Hospital
No.138, Sheng Li Road,Tainan, , Taiwan
China Medical University Hospital
No.2, Yuh-Der Rd.,Taichung, , Taiwan
Taipei Veterans General Hospital
No.201, Sec. 2, Shih-Pai Road, Taipei, , Taiwan
Chi Mei Medical Center Liou Ying Campus
No.201, Taikang Village, Liou Ying Township, Tainan, , Taiwan
Chang Gung Memorial Hospital, Lonkou
No.5, Fu-Hsing Saint Kuei Shan Hsiang, Taoyuan Hsien, , Taiwan
National Taiwan University Hospital
No.7, Chung San South Road, Taipei, , Taiwan
Chi Mei Medical Center
No.901, Chung Hwa Rd., Yong Kang City, Tainan, , Taiwan
Mackay Memorial Hospital, Taipei
No.92, Sec. 2, Zhongshan N. Rd., Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.
Ueno H, Okusaka T, Ikeda M, Takezako Y, Morizane C. An early phase II study of S-1 in patients with metastatic pancreatic cancer. Oncology. 2005;68(2-3):171-8. doi: 10.1159/000086771. Epub 2005 Jul 4.
Ueno H, Okusaka T, Ikeda M, Ishiguro Y, Morizane C, Matsubara J, Furuse J, Ishii H, Nagase M, Nakachi K. A phase I study of combination chemotherapy with gemcitabine and oral S-1 for advanced pancreatic cancer. Oncology. 2005;69(5):421-7. doi: 10.1159/000089997. Epub 2005 Nov 25.
Okusaka T, Miyakawa H, Fujii H, Nakamori S, Satoh T, Hamamoto Y, Ito T, Maguchi H, Matsumoto S, Ueno H, Ioka T, Boku N, Egawa S, Hatori T, Furuse J, Mizumoto K, Ohkawa S, Yamaguchi T, Yamao K, Funakoshi A, Chen JS, Cheng AL, Sato A, Ohashi Y, Tanaka M; GEST group. Updated results from GEST study: a randomized, three-arm phase III study for advanced pancreatic cancer. J Cancer Res Clin Oncol. 2017 Jun;143(6):1053-1059. doi: 10.1007/s00432-017-2349-y. Epub 2017 Feb 16.
Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
01023017
Identifier Type: -
Identifier Source: org_study_id