Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00303771
- Lead Sponsor
- Federation Francophone de Cancerologie Digestive
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.
PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer .
- Detailed Description
OBJECTIVES:
Primary
* Compare the progression-free survival of elderly patients with unresectable metastatic colorectal cancer treated with 1 of 2 different chemotherapy regimens comprising fluorouracil and leucovorin calcium with vs without irinotecan hydrochloride.
Secondary
* Compare the tumor response rate and 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.
OUTLINE: This is a randomized, multicenter, prospective study. Patients are stratified according to participating center, gender, Karnofsky score (60-70% vs 80-90% vs 100%), associated comorbidities (Charlson Index 0 vs 1-2 vs 3+), age (75 to 79 years vs ≥ 80 years), alkaline phosphatase level (≤ 2 times normal vs \> 2 times normal), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
* Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 22 hours on days 1 and 2.
* Arm II: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 2.
* Arm III: Patients receive leucovorin calcium and fluorouracil as in arm I and irinotecan hydrochloride IV over 90 minutes on day 1.
* Arm IV: Patients receive leucovorin calcium and fluorouracil as in arm II and irinotecan hydrochloride as in arm III.
In all arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Patients undergo surgery within 3-10 weeks after completing chemotherapy.
Quality of life is assessed at baseline and then every 2 months thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 282
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LV5FU2 simplifié fluorouracil LV5FU2 simplifié LV5FU2 classique fluorouracil LV5FU2 classique LV5FU2 classique leucovorin calcium LV5FU2 classique LV5FU2 simplifié leucovorin calcium LV5FU2 simplifié LV5FU2 classique + irinotécan leucovorin calcium LV5FU2 classique + irinotécan LV5FU2 simplifié+ irinotécan fluorouracil LV5FU2 simplifié + irinotécan LV5FU2 simplifié+ irinotécan irinotecan hydrochloride LV5FU2 simplifié + irinotécan LV5FU2 simplifié+ irinotécan leucovorin calcium LV5FU2 simplifié + irinotécan LV5FU2 classique + irinotécan irinotecan hydrochloride LV5FU2 classique + irinotécan LV5FU2 classique + irinotécan fluorouracil LV5FU2 classique + irinotécan
- Primary Outcome Measures
Name Time Method Progression Free Survival (survie sans progression) 2011 survie sans progression
- Secondary Outcome Measures
Name Time Method Overall Survival (survie globale) 2011 survie globale
Trial Locations
- Locations (77)
Clinique De Rochebelle
🇫🇷Ales, France
Centre hospitalier d'Alencon
🇫🇷Alencon, France
Centre Hospitalier d'Abbeville
🇫🇷Abbeville, France
Centre Hospitalier Universitaire d'Amiens
🇫🇷Amiens, France
Hopital Ambroise Pare
🇫🇷Boulogne-Billancourt, France
Centre Hospitalier de Chateaubriant
🇫🇷Chateaubriant cedex, France
Hopital Haut Leveque
🇫🇷Pessac, France
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
Hopital Tenon
🇫🇷Paris, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Hopital Cochin
🇫🇷Paris, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Nouvelle Clinique Generale
🇫🇷Valence, France
Centre Hospitalier D'Agen
🇫🇷Agen, France
Institut Sainte Catherine
🇫🇷Avignon, France
Centre Hospitalier Pierre Oudot
🇫🇷Bourgoin-Jallieu, France
Centre Medical de Bligny
🇫🇷Briis-Sous-Forges, France
Centre hospitalier de Charleville Mezieres
🇫🇷Charleville-Mezieres cedex, France
CHU Nord
🇫🇷Marseille, France
Centre Hospitalier General de Mont de Marsan
🇫🇷Mont-de-Marsan, France
Centre Gray
🇫🇷Maubeuge, France
Centre Hospitalier - Pau
🇫🇷Pau, France
Hopital Rene Dubos
🇫🇷Pontoise, France
CHU - Robert Debre
🇫🇷Reims, France
Polyclinique De Courlancy
🇫🇷Reims, France
Centre Hospitalier de Perpignan
🇫🇷Perpignan, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Hospitalier Universitaire de Rouen
🇫🇷Rouen, France
Pole Sante Sarthe et Loir Hopital Pierre Daguet
🇫🇷Sable Sur Sarthe, France
Hopital d'Instruction des Armees Begin
🇫🇷Saint-Mande, France
Centre Hospitalier de Saint-Quentin
🇫🇷Saint-Quentin, France
Center Hospitalier de Sens
🇫🇷Sens, France
Hopital Foch
🇫🇷Suresnes, France
Centre Hospitalier de Valenciennes
🇫🇷Valenciennes, France
Centre Hospitalier Intercommunal de la Haute-Saone
🇫🇷Vesoul, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Hospitalier de Vire
🇫🇷Vire, France
C.H. Bourg En Bresse
🇫🇷Bourg En Bresse, France
Centre Hospitalier Docteur Duchenne
🇫🇷Boulogne Sur Mer, France
Centre Hospitalier de Blois
🇫🇷Blois, France
Centre Hospitalier d'Annecy
🇫🇷Annecy, France
Hopital Duffaut
🇫🇷Avignon, France
Hopital Saint Andre
🇫🇷Bordeaux, France
Hopital Louis Pasteur
🇫🇷Colmar, France
Centre Hospitalier de Chalons-en-Champagne
🇫🇷Chalons-en-Champagne, France
Centre Hospitalier de Briey
🇫🇷Briey, France
Louis Mourier Hospital
🇫🇷Colombes Cedex, France
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
Centre Hospitalier de Digne les Bains
🇫🇷Digne Cedex, France
Hopital Du Bocage
🇫🇷Dijon, France
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
🇫🇷Elbeuf, France
CHU de Grenoble - Hopital Michallon
🇫🇷Grenoble, France
Centre Hospitalier de Dreux
🇫🇷Dreux, France
Clinique Saint Vincent
🇫🇷Epernay, France
Clinique Pasteur
🇫🇷Guilherand Granges, France
Centre Hospitalier de Haguenau
🇫🇷Haguenau, France
Centre Hospitalier Departemental
🇫🇷La Roche Sur Yon, France
Centre Hospitalier Universitaire de Bicetre
🇫🇷Le Kremlin Bicetre, France
Hopital Perpetuel Secours
🇫🇷Levallois, France
Hopital Robert Boulin
🇫🇷Libourne, France
Centre Hospitalier de Meaux
🇫🇷Meaux, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
Centre Hospitalier General
🇫🇷Longjumeau, France
Clinique Saint Jean
🇫🇷Lyon, France
Hopital Edouard Herriot - Lyon
🇫🇷Lyon, France
Centre Hospital Universitaire Hop Huriez
🇫🇷Lille, France
CHU de la Timone
🇫🇷Marseille, France
Centre Hospitalier de Martigues
🇫🇷Martigues, France
Hopital de l'Archet CHU de Nice
🇫🇷Nice, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Hospitalier de Nevers
🇫🇷Nevers, France
CHU de Nancy - Hopitaux de Brabois
🇫🇷Nancy, France
Centre Hospitalier d'Orange
🇫🇷Orange, France
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
🇫🇷Nimes, France
Hopital d'Instruction des Armees du Val de Grace
🇫🇷Paris, France
CHU Pitie-Salpetriere
🇫🇷Paris, France
Centre Hospitalier Valence
🇫🇷Valence, France