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Status:

COMPLETED

Radiation Therapy and Docetaxel With Either Fluorouracil or Cisplatin as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Lead Sponsor:

UNICANCER

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor...

Detailed Description

OBJECTIVES: Primary * Compare the 6-month progression-free survival rate in patients with unresectable metastatic adenocarcinoma of the pancreas treated with radiotherapy and docetaxel in combinatio...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • No other pancreatic tumor type, including either of the following:
  • Neuroendocrine tumor
  • Ampulla of Vater carcinoma
  • Metastatic disease
  • Measurable or evaluable disease
  • Unresectable disease, defined as either of the following:
  • Failed prior attempt of surgical resection by laparotomy
  • Surgical resection contraindicated by radiographic criteria (e.g., arterial vascular invasion)
  • No cerebral metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 to 75
  • Performance status
  • Karnofsky 70-100%
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Bilirubin \< 1.5 times upper limit of normal
  • No hepatic disturbance
  • Renal
  • Creatinine \< 120 mmol/L
  • Cardiovascular
  • No untreated cardiac or coronary insufficiency
  • No uncontrolled symptomatic arrhythmia
  • No uncontrolled angina
  • Pulmonary
  • No uncontrolled respiratory insufficiency
  • Other
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No peripheral neuropathy ≥ grade 2
  • No ongoing active infection
  • No other serious uncontrolled medical disorder that would preclude study treatment
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • No prior chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior radiotherapy to the celiac or pancreatic area
  • Surgery
  • See Disease Characteristics

Exclusion

    Key Trial Info

    Start Date :

    October 6 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2012

    Estimated Enrollment :

    71 Patients enrolled

    Trial Details

    Trial ID

    NCT00112697

    Start Date

    October 6 2003

    End Date

    March 1 2012

    Last Update

    February 17 2021

    Active Locations (10)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (10 locations)

    1

    Centre Paul Papin

    Angers, France, 49036

    2

    Centre Oscar Lambret

    Lille, France, 59020

    3

    Polyclinique des Quatre Pavillons

    Lormont, France, 33310

    4

    Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, France, 13273