NCT00498225

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
834

participants targeted

Target at P75+ for phase_3 pancreatic-cancer

Timeline
Completed

Started Jul 2007

Typical duration for phase_3 pancreatic-cancer

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 2, 2012

Status Verified

November 1, 2012

Enrollment Period

4 years

First QC Date

July 6, 2007

Last Update Submit

November 1, 2012

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Over all survival(OS)

    every course for first three courses, then every other course

Secondary Outcomes (1)

  • progression-free survival (PFS), response rate (RECIST, if measurable), incidence rate of adverse events, incidence rate of adverse drug reactions, QOL (EQ-5D)

    adverse events will be collected during treatment

Study Arms (3)

1

EXPERIMENTAL

Gemcitabine plus TS-1

Drug: Gemcitabine plus TS-1

2

EXPERIMENTAL

TS-1

Drug: TS-1

3

ACTIVE COMPARATOR

Gemcitabine

Drug: Gemcitabine

Interventions

Gemcitabine plus TS-1DRUG

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.

1
TS-1DRUG

TS-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 2week as one course.

2
GemcitabineDRUG

Gemcitabine was administered i.v. by 1000 mg/m2 at day 1, 8, 15 followed by 2 week rest as 1 course.

3

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28 days before enrollment).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

Chung-Ho Memorial Hospital, Kaohsiung Medical University

No.100, Tzyou 1st Rd., Kaohsiung, 807, Taiwan

Location

Chang Gung Memorial Hospital, Kaohsiung

No.123, Ta-Pei Rd., Niao-Sung Hsiang, Kaohsiung Hsien, 833, Taiwan

Location

Changhua Christian Hospital

No.135, Nanxiao St., Changhua, 500, Taiwan

Location

National Cheng Kung University Hospital

No.138, Sheng Li Road,Tainan, 704, Taiwan

Location

China Medical University Hospital

No.2, Yuh-Der Rd.,Taichung, 404, Taiwan

Location

Taipei Veterans General Hospital

No.201, Sec. 2, Shih-Pai Road, Taipei, 112, Taiwan

Location

Chi Mei Medical Center Liou Ying Campus

No.201, Taikang Village, Liou Ying Township, Tainan, 736, Taiwan

Location

Chang Gung Memorial Hospital, Lonkou

No.5, Fu-Hsing Saint Kuei Shan Hsiang, Taoyuan Hsien, 333, Taiwan

Location

National Taiwan University Hospital

No.7, Chung San South Road, Taipei, 100, Taiwan

Location

Chi Mei Medical Center

No.901, Chung Hwa Rd., Yong Kang City, Tainan, 710, Taiwan

Location

Mackay Memorial Hospital, Taipei

No.92, Sec. 2, Zhongshan N. Rd., Taipei, 104, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 9196156BACKGROUND

  • 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.

    PMID: 16006754BACKGROUND

  • 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.

    PMID: 16319514BACKGROUND

  • 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.

    PMID: 28210843DERIVED

  • 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.

    PMID: 23547081DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabinetitanium silicide

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Takuji Okusaka, MD

    National Cancer Center Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 9, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2011

Study Completion

June 1, 2012

Last Updated

November 2, 2012

Record last verified: 2012-11

Locations

JP(1)TW(11)