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Pancreatic CancerPhase 2NCT00010062

Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer

A Phase 2 study testing fluorouracil and radiation therapy in people with Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 30 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
fluorouracil and radiation therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
30 sitesin 2 countries
Study dates
Oct 2000to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed pancreatic adenocarcinoma
  • Complete macroscopic resection of tumor within past 30 days
  • No residual visceral or peritoneal metastasis
  • Involvement of Vater's ampulla or extrahepatic bile duct allowed
  • No vesicular or intrahepatic cholangiocarcinomas

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Alkaline phosphatase less than 3 times normal
  • Bilirubin less than 1.5 times normal

Renal:

  • Creatinine less than 1.5 times normal

Cardiovascular:

  • No serious cardiac failure

Pulmonary:

  • No serious respiratory failure

Other:

  • No other untreatable malignant tumors
  • No serious psychological, familial, social, or geographical conditions that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for pancreatic adenocarcinoma

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for pancreatic adenocarcinoma
  • No prior radiotherapy in an anatomically proximal region to treatment area

Surgery:

  • See Disease Characteristics

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

France29 sites

  • Clinique De Savoie

    Annemasse, 74100

  • Clinique Floreal

    Bagnolet, 28630

  • Clinique Tivoli

    Bordeaux, F-33030

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Clinique Saint - Jean

    Cagne-sur-Mer, 06800

  • Polyclinique Saint Jean

    Cagnes-sur-Mer

  • Hopital Fontenoy

    Chartres, 28018

  • Hopital Beaujon

    Clichy, 92118

  • Hopital Louis Mourier

    Colombes

  • Hopital Drevon

    Dijon, 21000

  • Clinique Claude Bernard

    Ermont, 95120

  • Clinique Pasteur

    Évreux, 27000

  • Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie

    Gien, 45500

  • CHR de Grenoble - La Tronche

    Grenoble, F-38043

  • Hopital Saint - Louis

    La Rochelle, 17000

  • Centre Jean Bernard

    Le Mans, 72000

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Hopital Laennec

    Paris, 75007

  • Hopital Saint Antoine

    Paris, 75571

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Hopital Tenon

    Paris, 75970

  • Clinique Ste - Marie

    Pontoise, 95301

  • Hopital Claude Gallien

    Quincy-sous-Sénart, 91480

  • Polyclinique De Courlancy

    Reims, F-51100

  • Clinique Saint Vincent

    Saint-Grégoire, 35700

  • Centre du Rouget

    Sarcelles, 95250

  • C.H. Senlis

    Senlis, 60309

  • Centre Medico-Chirurgical Foch

    Suresnes, 92151

  • Clinique Pasteur

    Toulouse, 31076

Other trials in France

Luxembourg1 site

  • Hopital de la Ville D'Esch-sur-Alzette

    Esch-sur-Alzette, L-4005

Other trials in Luxembourg

About this study

Official title: Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.

PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.

Read the detailed description

OBJECTIVES:

  • Determine the tolerance of adjuvant fluorouracil with concurrent radiotherapy in patients with resected pancreatic adenocarcinoma.
  • Determine survival without local relapse in these patients treated with this regimen.
  • Determine overall survival of these patients treated with this regimen.
  • Determine the effectiveness of this adjuvant therapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive high-dose radiotherapy 5 days a week for 5 weeks. Patients also receive low-dose radiotherapy 4 times a week during the last 2 weeks of the 5-week course of treatment. Patients concurrently receive fluorouracil IV continuously for 5 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Being tested
fluorouracil, radiation therapy
Keywords
stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00010062
Sponsor's protocol ID
CDR0000068438
Other IDs
FRE-GERCOR-D98-1, EU-20022
Status last verified
Apr 2007
First submitted
2 Feb 2001
Last updated
9 Feb 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fluorouracil and radiation therapy in people with Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00010062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2009.

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