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Colorectal CancerPhase 3NCT00004150

High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer

A Phase 3 study testing fluorouracil, leucovorin calcium and adjuvant therapy in people with Colorectal Cancer, run by Robert Roessle Klinik at 85 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. It is not yet known which chemotherapy regimen is more effective for colon cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
fluorouracil, leucovorin calcium and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
85 sitesin 6 countries
Study dates
Mar 1999to Apr 2007
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III adenocarcinoma or mucinous adenocarcinoma of the colon
  • Must have had curative radical resection within 56 days prior to study
  • No local tumor therapy (i.e., polypectomy, local excision or limited intestinal resection)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 10.0 g/dL

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No severe coronary heart disease
  • No New York Heart Association class III or IV heart failure

Other:

  • No other malignancy within the past 10 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
  • No uncontrolled infection
  • No other severe disease
  • No known allergy to leucovorin calcium
  • No known familial adenomatous polyposis, Crohn's disease, or ulcerative colitis
  • No hereditary syndrome (e.g., Gardner's syndrome, Turcot's syndrome, hereditary nonpolyposis colon cancer)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for colon cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for colon cancer

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent systemic anticancer therapy

Trial locations and contacts

85 sites in 6 countries.

85 sites in 6 countries

France39 sites

  • Centre Hospitalier Regional et Universitaire d'Angers

    Angers, 49033

  • Clinique St. Etienne

    Bayonne, 64100

  • Centre Hospitalier General

    Belfort, 90000

  • CHR de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Clinique du Cedre

    Bois-Guillaume, 76230

  • CHU Ambroise Pare

    Boulogne-Billancourt, F-92104

  • Centre Hospitalier de Bourgoin - Jallieu

    Bourgoin, 38300

  • Centre Hospitalier General

    Brivé, 19101

  • CHU de Caen

    Caen, 14033

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier de Chalons - en - Champagne

    Châlons-en-Champagne, 51000

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21034

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Clinique Pasteur

    Évreux, 27000

  • Cabinet de Gastro-Enterologie

    Les Sables-d'Olonne, 85100

  • Centre Hospital Universitaire Hop Huriez

    Lille, 59037

  • Hopital de la Croix Rousse

    Lyon, 69317

  • Hopital Saint Joseph

    Marseille, 13008

  • Centre Hospitalier de Meaux

    Meaux, 77104

  • Clinique du Pont de Chaume

    Montauban, 82017

  • Hopital St. Eloi

    Montpellier, 34295

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Hopital de l'Archet

    Nice, F-06202

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45100

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Cochin

    Paris, 75674

  • Clinique Ste - Marie

    Pontoise, 95301

  • Institut Jean Godinot

    Reims, 51056

  • Polyclinique De Courlancy

    Reims, F-51100

  • Centre Hospitalier D'Agen

    Saint-Esprit, 47000

  • Centre Hospitalier General de Saint Nazaire

    Saint-Nazaire, 44600

  • Centre Paul Strauss

    Strasbourg, 67065

  • CHU Rangueil

    Toulouse, 31403

  • Nouvelle Clinique Generale

    Valence, 26000

  • CHU de Nancy - Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Centre Hospitalier General - St. Nicolas

    Verdun, 55107

  • Centre Hospitalier Regionale de Vichy

    Vichy, 03201

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Spain36 sites

  • Hospital General

    Albacete, 2006

  • Hospital Virgen de los Lirios

    Alcoi Alicante, 03800

  • Hospital General - Alicante

    Alicante, 3010

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital de Barbastro

    Barbastro, 22300

  • Hospital Del Mar

    Barcelona, 08003

  • Institut d'Oncologia Corachan

    Barcelona, 08017

  • Hospital de la Santa Cruz I Sant Pau

    Barcelona, 08025

  • Hospital General Universitari Vall d'Hebron

    Barcelona, 08035

  • Consorci Hospitalari de la Creu Roia

    Barcelona, 08906

  • Hospital de L'esperit Sant

    Barcelona, 08923

  • Hospital Universitario Puerta Del Mar

    Cadiz, 11000

  • Hospital Universarito "Reina Sofia"

    Córdoba, 14004

  • Hospital Virgen de Luz

    Cuenca, 16002

  • Hospital Universitario de Elche

    Elche Alicante, E-03203

  • Hospital General Virgen de las Nieves

    Granada, 18014

  • Hospital General Universitario De Guadalajara

    Guadalajara, 19002

  • Residencia Sanitaria de Jaen

    Jaén, 23007

  • Hospital General de Jerez

    Jerez de la Frontera, 11407

  • Fundacion Jimenez Diaz - Clin. N.S.

    Madrid, 28040

  • Hospital Universitario San Carlos

    Madrid, 28040

  • Hospital Regional Carlos Haya De Malaga

    Málaga, 29010

  • Hospital De Merida

    Mérida, 06800

  • Hospital De Navarra

    Pamplona, 31008

  • Consorci Hospitalari del Parc Tauli

    Sabadell, 08208

  • Hospital de Sagunto

    Sagunto, 46520

  • Hospital Virgen de la Vega

    Salamanca, 37007

  • Hospital Universitario Canarias

    San Cristóbal de La Laguna, 38320

  • Hospital Universitari Sant Joan d'Alacant

    San Juan, 3550

  • Hospital - Residencia Sant Camil

    Sant Pere de Ribes, 08810

  • Hospital Ntra. Sra. de la Candelaria

    Santa Cruz de Tenerife, 38003

  • Hospital Consorci Sanitari De Terrassa

    Terrassa, 08227

  • Instituto Valenciano De Oncologia

    Valencia, 46009

  • Hospital General Universitario Valencia

    Valencia, 46014

  • Hospital Txagorritxu

    Vitoria-Gasteiz, 01009

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Belgium7 sites

  • Ziekenhuis Network Antwerpen Middelheim

    Antwerp, B-2020

  • Institut Jules Bordet

    Brussels, 1000

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • CHU Liege - Domaine Universitaire du Sart Tilman

    Liège, B-4000

  • Centre Hospitalier Peltzer-La Tourelle

    Verviers, B-4800

Other trials in Belgium

Germany1 site

  • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

    Berlin, D-13122

Other trials in Germany

Netherlands1 site

  • Saint Laurentius Ziekenhuis

    Roermond, 6043 CV

Other trials in Netherlands

Serbia1 site

  • Institute of Oncology and Radiology of Serbia

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: Pan-European Trials in Adjuvant Colon Cancer (PETACC-2): Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU (+ or - Folinic Acid) Versus Standard Bolus 5-FU/Folinic Acid

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer.

PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.

Read the detailed description

OBJECTIVES:

  • Compare recurrence-free survival and duration of survival in patients with stage III adenocarcinoma of the colon treated with adjuvant high-dose fluorouracil with or without leucovorin calcium versus standard fluorouracil with leucovorin calcium following curative radical resection.
  • Compare the safety of these regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to regional lymph node involvement (N1 (1-3 pericolic lymph nodes) vs N2 (more than 3 pericolic lymph nodes) and participating center.

Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive leucovorin calcium IV followed by fluorouracil IV on days 1-5. Treatment repeats every 4 weeks for 6 courses.
  • Arm II: Patients receive high-dose fluorouracil IV continuously over 48 hours weekly for 8 weeks. Treatment repeats every 8 weeks for 3 courses.

OR

  • Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours weekly for 6 weeks. Treatment repeats every 7 weeks for 3 courses.

OR

  • Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV bolus and then fluorouracil IV continuously over 22 hours on days 1 and 2. Treatment repeats every 2 weeks for 12 courses.

Patients are followed at 1 month, every 6 months for 4.5 years, and then annually thereafter until death.

PROJECTED ACCRUAL: Approximately 1,600 patients (800 per treatment arm) will be accrued for this study within 3 years.

Keywords
stage III colon cancer, adenocarcinoma of the colon, mucinous adenocarcinoma of the colon
Medical subject headings
Colorectal Neoplasms, Colonic 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 startMar 1999
  3. Study completionApr 2007

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 3
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004150
Sponsor's protocol ID
CDR0000067383
Other IDs
PETACC-2, EORTC-40963, FFCD-PETACC-2, GETTD-PETACC-2
Status last verified
Feb 2001
First submitted
10 Dec 1999
Last updated
6 Nov 2013
Results posted
No

Publications

  • Fensterer H, Radlwimmer B, Strater J, Buchholz M, Aust DE, Julie C, Radvanyi F, Nordlinger B, Belluco C, Van Cutsem E, Kohne CH, Kestler HA, Schwaenen C, Nessling M, Lutz MP, Lichter P, Gress TM; EORTC Gastrointestinal (GI) Group. Matrix-comparative genomic hybridization from multicenter formalin-fixed paraffin-embedded colorectal cancer tissue blocks. BMC Cancer. 2007 Apr 2;7:58. doi: 10.1186/1471-2407-7-58.

    PubMed 17407575

  • Carrato A, Köhne C, Bedenne L, et al.: Folinic acid modulated bolus 5-FU or infusional 5-FU for adjuvant treatment of patients of UICC stage III colon cancer: preliminary analysis of the PETACC-2-study. [Abstract] J Clin Oncol 24 (Suppl 18): A-3563, 2006.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fluorouracil, leucovorin calcium and adjuvant therapy in people with Colorectal Cancer, run by Robert Roessle Klinik at 85 sites in 6 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: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in France, Spain, Belgium, Germany, Netherlands and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 NCT00004150, which also lists 2 linked publications.

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 6 Nov 2013.

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