CClinicalTrials.gg
CompletedNCT00112697Updated Feb 17, 2021

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

A Phase 2 interventional study of cisplatin and docetaxel in Pancreatic Cancer, sponsored by UNICANCER. Completed at 10 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by UNICANCER · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Oct 2003, registered Jun 2005).
Phase
Phase 2
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

Read the 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 combination with either fluorouracil or cisplatin as first-line therapy.

Secondary

  • Compare the toxicity of these regimens in these patients.
  • Compare the objective response rate in patients treated with these regimens.
  • Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiotherapy to the celiac area once daily 5 days a week for 6 weeks. Patients also receive docetaxel IV weekly and fluorouracil IV daily for 6 weeks.
  • Arm II: Patients undergo radiotherapy and receive docetaxel as in arm I. Patients also receive cisplatin IV weekly for 6 weeks.

In both arms, patients experiencing disease progression after completion of chemoradiotherapy may receive additional courses of chemotherapy.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 3 years.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 71 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

UNICANCER is the lead sponsor of 215 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: docetaxel · Drug: fluorouracil · Radiation: radiation therapy

  • Experimental
    Arm 2

    Drug: cisplatin · Drug: docetaxel · Radiation: radiation therapy

Interventions

  • Drugcisplatin
  • Drugdocetaxel
  • Drugfluorouracil
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Progression-free survival rate at 6 months

Secondary outcomes

  1. Toxicity

  2. Objective response rate

  3. Overall survival

07

Study locations

10 sites
  • Centre Paul Papin
    Angers, 49036, France
  • Centre Oscar Lambret
    Lille, 59020, France
  • Polyclinique des Quatre Pavillons
    Lormont, 33310, France
  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
    Marseille, 13273, France
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
    Montpellier, 34298, France
  • Centre Regional Rene Gauducheau
    Nantes-Saint Herblain, 44805, France
  • Centre Hospitalier Lyon Sud
    Pierre Benite, 69495, France
  • Centre Rene Huguenin
    Saint Cloud, 92210, France
  • Centre Alexis Vautrin
    Vandoeuvre-les-Nancy, 54511, France
  • Institut Gustave Roussy
    Villejuif, F-94805, France
08

References and documents

Publications

  • Oberic L, Viret F, Baey C, Ychou M, Bennouna J, Adenis A, Peiffert D, Mornex F, Pignon JP, Celier P, Berille J, Ducreux M. Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival. Radiat Oncol. 2011 Sep 26;6:124. doi: 10.1186/1748-717X-6-124. PubMed 21943032 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00112697
Lead sponsor
UNICANCER
Responsible party
Sponsor
First posted
Jun 3, 2005
Start date
Oct 6, 2003
Primary completion
Aug 1, 2008
Completion
Mar 1, 2012
Last update
Feb 17, 2021

Study contacts

Michel Ducreux, MD, PhD
study chair · Gustave Roussy, Cancer Campus, Grand Paris

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion