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Colorectal CancerPhase 3NCT00005979

Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer

A Phase 3 study testing FOLFIRI regimen, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by UNICANCER at 30 sites in France.

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. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
FOLFIRI regimen, fluorouracil and irinotecan hydrochloride
How many people
Not given
Where
30 sitesFrance
Study dates
22 Jul 1998to 1 Sep 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically proven stage III adenocarcinoma of the colon that has been curatively resected within past 42 days
  • No metastatic disease
  • Node positive
  • No more than 4 nodes affected (Tx, N2, M0) AND/OR
  • N1 or N2 with perforation and/or occlusion
  • No prior rectal cancer within 10 cm of anal margin or that was treated with preoperative radiotherapy
  • No prior inflammatory disease of the intestine

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Neutrophil count at least 2,000/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin less than 1.25 times upper limit of normal (ULN)
  • SGOT and SGPT less than 3 times ULN
  • Alkaline phosphatase less than 3 times ULN

Renal:

  • Not specified

Cardiovascular:

  • No myocardial infarction within past 6 months
  • No insufficient cardiac function

Other:

  • No other serious medical illness
  • No active infection
  • No other malignancy except skin cancer or carcinoma in situ of the cervix
  • No psychological or social condition that would preclude study
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics
  • No prior extensive intestinal resection

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

France30 sites

  • Centre Paul Papin

    Angers, 49036

  • Clinique St. Etienne

    Bayonne, 64100

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Hospitalier de Fleyriat

    Bourg-en-Bresse, 01012

  • Centre Hospitalier de Bourgoin - Jallieu

    Bourgoin, 38300

  • Centre Hospitalier General

    Brivé, 19101

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94010

  • Faculte de Medecine

    Dijon, 21033

  • Hopital Du Bocage

    Dijon, 21034

  • Centre Hospitalier Maie Madeleine

    Forbach, 57600

  • Centre Leon Berard

    Lyon, 69008

  • Institut J. Paoli and I. Calmettes

    Marseille, 13273

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

    Montpellier, 34298

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45067

  • Institut Jean Godinot

    Reims, 51056

  • St Joseph's Medical Center

    Reims, 51056

  • Centre Hospitalier Universitaire

    Reims, 51092

  • Centre Eugene Marquis

    Rennes, 35064

  • Hopital Charles Nicolle

    Rouen, 76031

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Hopitaux Universitaire de Strasbourg

    Strasbourg, 67091

  • Centre Hospitalier de Tarbes

    Tarbes, 65013

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Hospitalier Valence

    Valence, 26000

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Centre Hospitalier P. Chubert

    Vannes, 56260

  • Centre Hospitalier Regionale de Vichy

    Vichy, 03201

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

Official title: Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer.

Read the detailed description

OBJECTIVES:

  • Compare the effect of leucovorin calcium and fluorouracil with or without irinotecan on the 3 year survival rate and overall survival of patients with resected node positive colon cancer at high risk of recurrence.
  • Compare toxicities of these regimens in these patients.
  • Compare quality of life of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, disease type (occlusion vs perforation vs N2 only), delay between surgery and chemotherapy (28 days or less vs over 28 days), and age (under 65 vs 65 and over). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2.
  • Arm II: Patients receive irinotecan IV over 90 minutes on day 1 followed by leucovorin calcium and fluorouracil as in arm I.

Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before treatment, after 6 and 12 courses, and then at 1 year.

Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study within 3 years.

Keywords
stage III colon cancer, 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 start22 Jul 1998
  3. Primary completion26 Sep 2005
  4. Study completion1 Sep 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
NCT00005979
Sponsor's protocol ID
CDR0000067967
Other IDs
FRE-FNCLCC-ACCORD-2, FFCD-9802, EU-20014
Status last verified
Feb 2021
First submitted
5 Jul 2000
Last updated
17 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ychou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, Viret F, Becouarn Y, Bouche O, Gamelin E, Ducreux M, Conroy T, Seitz JF, Bedenne L, Kramar A. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009 Apr;20(4):674-80. doi: 10.1093/annonc/mdn680. Epub 2009 Jan 29.

    PubMed 19179549

  • Cote JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, Thirouard AS, Selves J, Laurent-Puig P, Ychou M. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res. 2007 Jun 1;13(11):3269-75. doi: 10.1158/1078-0432.CCR-06-2290. Epub 2007 May 17.

    PubMed 17510208

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FOLFIRI regimen, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by UNICANCER at 30 sites in France.

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 17 Feb 2021. 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. 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 NCT00005979, 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 17 Feb 2021.

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