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Colorectal CancerPhase 3MIROXNCT00268398

Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases

A Phase 3 study testing oxaliplatin, folinic acid, fluorouracil and oxaliplatin, irinotecan, folinic acid, fluorouracil in people with Colorectal Cancer and Metastatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 32 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

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer, Metastatic Cancer, Chemotherapy
What is being tested?
oxaliplatin, folinic acid, fluorouracil and oxaliplatin, irinotecan, folinic acid, fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
284 participants
Where
32 sitesFrance
Study dates
Jul 2002to Dec 2011
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

MAIN ELIGIBILITY CRITERIA

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the colon or rectum
  • Resectable or resected metastatic disease,

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times normal
  • Creatinine ≤ 135 mmol/L or creatinine clearance ≥ 60 mL/min
  • SGOT and SGPT ≤ 3 times ULN
  • No peripheral neuropathy that affects normal functions
  • No unresolved complications from prior surgery

PRIOR CONCURRENT THERAPY:

  • At least 1 year since prior FOLFOX 4 or FOLFIRI regimen in the adjuvant setting
  • No concurrent participation in another clinical trial
  • Recovered from prior therapy

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

France32 sites

  • Institut Sainte Catherine

    Avignon, 84000

  • Hopital Duffaut

    Avignon, 84902

  • C.H.G. Beauvais

    Beauvais, 60021

  • Hopital Saint Andre

    Bordeaux, 33075

  • Hopital Ambroise Pare

    Boulogne-Billancourt, F-92104

  • Centre Hospitalier Docteur Duchenne

    Boulogne-sur-Mer, 62200

  • Centre Hospitalier de Briey

    Briey, 54151

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Hopital Louis Pasteur

    Chartres, 28018

  • Hopital Beaujon

    Clichy, 92118

  • Louis Mourier Hospital

    Colombes, 92701

  • Clinique du Parc

    Croix, 59170

  • Hopital Drevon

    Dijon, 21000

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • Hopital Saint - Louis

    La Rochelle, 17000

  • Hopital Robert Boulin

    Libourne, 33500

  • Polyclinique Du Bois

    Lille, 59000

  • Centre Hospital Universitaire Hop Huriez

    Lille, 59037

  • Polyclinique des Quatre Pavillons

    Lormont, 33310

  • Hopital Saint Joseph

    Marseille, 13008

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038

  • Centre Hospitalier Intercommunal Le Raincy - Montfermeil

    Montfermeil, 93370

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Saint Antoine

    Paris, 75571

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Hopital Tenon

    Paris, 75970

  • Hopital Haut Leveque

    Pessac, 33604

  • Polyclinique De Courlancy

    Reims, F-51100

  • Clinique Specialise du Littoral-Cote d'Opale

    Saint-Martin-Boulogne, 62280

  • Clinique Charcot

    Sainte-Foy-lès-Lyon, 69110

  • C.H. Senlis

    Senlis, 60309

  • Hopital Foch

    Suresnes, 92151

Other trials in France

About this study

Official title: Essai De Phase III De Chimiotherapie Par FOLFOX 4 Ou Par Une Succession FOLFOX 7 - FOLFIRI Chez Des Patients Ayant Des Metastases Resecables D'Origine Colorectale - MIROX

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the 2-year disease-free survival rate in patients treated with these regimens.

Secondary

  • Compare the overall survival of patients treated with these regimens.
  • Compare the tolerability of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the objective response rate, postoperative complication rate, and transfusing rate in patients having metastasis surgery,
  • Determine the pharmacogenetics of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter phase III study. Patients are stratified according to prior chemotherapy (perioperative vs postoperative), prior treatment (surgery only vs radiotherapy with or without surgery), and Blumgart score (0-1 vs 2-3 vs 4-5). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (FOLFOX 4): Patients receive FOLFOX 4 combination chemotherapy comprising oxaliplatin 85mg/m² IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV bolus /15min and fluorouracil continuously over 22 hours on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II (FOLFOX 7 and FOLFIRI): Patients receive FOLFOX 7 combination chemotherapy comprising high-dose oxaliplatin 130mg/m² IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive FOLFIRI combination chemotherapy comprising irinotecan hydrochloride 180mg/m² IV over 30-90 minutes and leucovorin calcium and fluorouracil IV bolus /15min on day 1, and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients in both arms who have undergone prior resection of metastatic lesions may undergo surgery after 6 courses of chemotherapy or after chemotherapy is completed.

Quality of life is assessed at baseline and after courses 4, 8, and 12.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 284 patients will be accrued for this study.

Being tested
oxaliplatin, folinic acid, fluorouracil, oxaliplatin, irinotecan, folinic acid, fluorouracil
Keywords
adenocarcinoma of the colon, stage IV colon cancer, adenocarcinoma of the rectum, stage IV rectal cancer, resectable metastases
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

  • oxaliplatin, folinic acid, fluorouracilDrug

    folinic acid 200 mg/m² (day 1\&2) oxaliplatin 85 mg/m² (day 1) bolus 5FU 400 mg/m² (day 1\&2) continuous 5FU 600mg/m² (day 1 to 2)

  • oxaliplatin, irinotecan, folinic acid, fluorouracilDrug

    FOLFOX7 folinic acid 400 mg/m² (day 1) oxaliplatin 130 mg/m² (day 1) continuous 5FU 3000mg/m² (day 1 to 2)

    FOLFIRI folinic acid 400 mg/m² (day 1) irinotecan 180 mg/m² (day 1) bolus 5FU 400 mg/m² (day 1) continuous 5FU 2400mg/m² (day 1 to 2)

Study groups in NCT00268398
Study groupRoleWhat they receive
FOLFOX4Active comparatorNot described
Receives: Drug: oxaliplatin, folinic acid, fluorouracil
FOLFOX7 followed by FOLFIRIExperimentalNot described
Receives: Drug: oxaliplatin, irinotecan, folinic acid, fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. disease-free survival

    Measured: 2-year

Secondary outcomes (4)

  1. Overall survival

    Measured: 2-year, 3-year, 5-year

  2. Tolerability

    Measured: 2-year

  3. Quality of life

    Measured: 2-year

  4. Pharmacogenetics

    Measured: 2-year

Timeline

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

  1. First posted22 Dec 2005 (estimated)
  2. Study startJul 2002
  3. Primary completionDec 2011

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
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00268398
Sponsor's protocol ID
CDR0000453815
Other IDs
GERCOR-C02-1, GERCOR-C02-1-MIROX, EU-20567, SANOFI-GERCOR-C02-1
Acronym
MIROX
Status last verified
May 2012
First submitted
20 Dec 2005
Last updated
22 May 2012
Results posted
No

Publications

  • Hamidou Z, Chibaudel B, Hebbar M, Hug de Larauze M, Andre T, Louvet C, Brusquant D, Garcia-Larnicol ML, de Gramont A, Bonnetain F. Time to Definitive Health-Related Quality of Life Score Deterioration in Patients with Resectable Metastatic Colorectal Cancer Treated with FOLFOX4 versus Sequential Dose-Dense FOLFOX7 followed by FOLFIRI: The MIROX Randomized Phase III Trial. PLoS One. 2016 Jun 16;11(6):e0157067. doi: 10.1371/journal.pone.0157067. eCollection 2016.

    PubMed 27310205

  • Hebbar M, Chibaudel B, Andre T, Mineur L, Smith D, Louvet C, Dutel JL, Ychou M, Legoux JL, Mabro M, Faroux R, Auby D, Brusquant D, Khalil A, Truant S, Hadengue A, Dalban C, Gayet B, Paye F, Pruvot FR, Bonnetain F, Landi B, Flesch M, Carola E, Martin P, Vaillant E, de Gramont A; Group Cooperateur Multidisciplinaire en Oncologie (GERCOR) Group. FOLFOX4 versus sequential dose-dense FOLFOX7 followed by FOLFIRI in patients with resectable metastatic colorectal cancer (MIROX): a pragmatic approach to chemotherapy timing with perioperative or postoperative chemotherapy from an open-label, randomized phase III trial. Ann Oncol. 2015 Feb;26(2):340-7. doi: 10.1093/annonc/mdu539. Epub 2014 Nov 17.

    PubMed 25403578

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing oxaliplatin, folinic acid, fluorouracil and oxaliplatin, irinotecan, folinic acid, fluorouracil in people with Colorectal Cancer and Metastatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 32 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 22 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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.

What does the primary outcome measure?

disease-free survival (time frame: 2-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00268398, 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 22 May 2012.

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