GEM vs GEM+TS-1 for Advanced Pancreatic Cancer

NCT00514163 | Completed Phase 2 DMC

• 1 other identifier: JACCRO PC-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+S-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer

Conditions

Pancreatic Cancer

Keywords

pancreatic carcinoma; gemcitabine; S-1; phaseⅡstudy

Outcome Measures

Primary Outcomes (1)

• response rate

  during observation

Secondary Outcomes (4)

• median survival time(MST)

  during observation

• time-to-progression(TTP)

  from onset of regression to progression

• toxicity

  during observation

• clinical benefit response

  during observation

Study Arms (2)

1

EXPERIMENTAL

gemcitabine + S-1

Drug: gemcitabine + S-1

2

ACTIVE COMPARATOR

S-1

Drug: gemcitabine

Interventions

gemcitabine + S-1 DRUG

gemcitabine on day one and 8th S-1 po days 1 to14 every 3 weeks

Also known as: gemzar, TS-1

1

gemcitabine DRUG

gemcitabine DIV on day one , 8th and 15th

Also known as: gemzar

2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven unresectable pancreatic carcinoma
• There must be measurable lesions with multislice CT
• ECOG Performance status 0-2
• No other active cancer
• No previous therapy such as radiotherapy, chemotherapy and immunotherapy
• Adequate organ functions are preserved as WBC more than 4000/mm3,Hb more than 8.0g/dl,neutrophil more than 2000/mm3,platlet more than 100,000/mm3, AST less than 2.5 x normal or less than 5.0 x normal if the patient had known liver metastasis, bilirubin less than 2.0mg/dl, Ccr more than 60ml/min
• No serious complications
• Be able to eat food
• Life expectancy of more than 8 weeks duration
• Informed consent is obtained-

You may not qualify if:

• Interstitial pneumonia
• Uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months
• Serious infection
• Pregnant or lactating females
• History of serious drug allergy
• Serious other complications
• Uncontrolled mental disorders -

Sponsors & Collaborators

• Japan Clinical Cancer Research Organization: lead

Study Sites (1)

Cancer Institute Ariake Hospital

Tokyo, 135-8550, Japan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; S 1 (combination); titanium silicide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Takaaki Ikari, MD. PhD

  Cancer Institute Ariake Hospital

  PRINCIPAL INVESTIGATOR

• Masafumi Suyama, M.D. PhD

  Juntenndo University Hospital

  PRINCIPAL INVESTIGATOR

• Naoto Egawa, M.D. PhD

  Komagome Hospital

  PRINCIPAL INVESTIGATOR

• Yasuji Omuro, M.D. PhD

  Komagome Hospital

  PRINCIPAL INVESTIGATOR

• Takao Itoi, M.D. PhD

  Tokyo Medical college

  PRINCIPAL INVESTIGATOR

• Atsushi Sofuni, M.D. PhD

  Tokyo medical college

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

JP (1)