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Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)


Inclusion Criteria:



- Histologic or cytologic diagnosis pancreatic cancer

- inoperable stage II or stage III or IV disease(UICC, 1997)

- Age 18 to 75 years

- Karnofsky Performance status > 50

- Signed informed consent

Exclusion Criteria:

- Previous chemotherapy

- Cerebral metastases

- Previous malignancies in past 5 years excluding adequately treated basal or
spinocellular skin cancers and insitu cervical cancer

- Leukocytes < 4000 or neutrophils < 2000 or platelets < 100000 or hemoglobin < 10 g/dl

- Creatinine value > upper normal limit

- GOT or GPT > 2.5 times upper normal limit or bilirubin > 1.5 times upper normal limit
in absence of hepatic metastases

- Congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease

- Other concurrent disease that would, in the investigator's opinion, contraindicate
the use of the study drugs

- Inability to provide informed consent

- Inability to comply with follow-up.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

9 months

Safety Issue:

No

Principal Investigator

Giuseppe Colucci, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Tumori Giovanni Paolo II

Authority:

Italy: Ethics Committee

Study ID:

GIP-1

NCT ID:

NCT00813696

Start Date:

April 2002

Completion Date:

September 2009

Related Keywords:

  • Pancreatic Cancer
  • chemotherapy
  • advanced cancer
  • inoperable
  • Stage II, III, IV
  • Pancreatic Neoplasms

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