Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer
NCT ID: NCT01910610
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
464 participants
INTERVENTIONAL
2013-10-30
2024-12-31
Brief Summary
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Detailed Description
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STRATEGY A: FOLFIRI-cetuximab, followed by oxaliplatin-based chemotherapy with bevacizumab vs.
STRATEGY B: OPTIMOX-bevacizumab, followed by irinotecan-based chemotherapy with bevacizumab, followed by anti-EGFR mab with or without irinotecan.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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STRATEGY A
FOLFIRI-cetuximab, followed by oxaliplatin-based chemotherapy with bevacizumab
FOLFIRI-cetuximab
mFOLFOX6-bevacizumab
XELOX + bevacizumab
STRATEGY B
OPTIMOX-bevacizumab, followed by irinotecan-based chemotherapy with bevacizumab, followed by anti-EGFR mab with or without irinotecan
OPTIMOX-bevacizumab
irinotecan-based chemo + bevacizumab
Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab)
XELOX + bevacizumab
Interventions
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FOLFIRI-cetuximab
mFOLFOX6-bevacizumab
OPTIMOX-bevacizumab
irinotecan-based chemo + bevacizumab
Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab)
XELOX + bevacizumab
Eligibility Criteria
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Inclusion Criteria
2. Histologically proven adenocarcinoma of the colon and/or rectum,
3. Wild-type RAS tumor no mutation in exon 2 \[codon 12/13\], exon 3 \[codon 59/61\] and exon 4 \[codon 117/146\] of both KRAS and NRAS genes (local assessment, performed either on primary tumor or metastasis), In exceptional circumstances, RAS mutational status (KRAS and NRAS) can be pending at time of randomization, provided it is obtained within the first two cycles of first line therapy
4. Metastatic disease confirmed,
5. No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be \>6 months for fluoropyrimidine alone or \>12 months for oxaliplatin-based, bevacizumab-based, or cetuximab-based therapy),
6. Duly documented unresectable metastatic disease, ie not suitable for complete carcinological surgical resection at inclusion \[NB: patients with unresectable disease at study entry but with any potential of salvage surgery after induction therapy are eligible\],
7. At least one measurable or evaluable lesion as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1,
8. Age ≥18 years,
9. ECOG Performance status (PS) 0-2,
10. Hematological status: neutrophils (ANC) ≥1.5x109/L; platelets ≥100x109/L; haemoglobin ≥9g/dL,
11. Adequate renal function: serum creatinine level \<150µM,
12. Adequate liver function: serum bilirubin ≤1.5 x upper normal limit (ULN), alkaline phosphatase \<5xULN,
13. Proteinuria \<2+ (dipstick urinalysis) or ≤1g/24hour,
14. Baseline evaluations performed before randomization when the KRAS WT status is known: clinical and blood evaluations no more than 2 weeks (14 days) prior to randomization, tumor assessment (CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days) prior to randomization,
15. Female patients must commit to using reliable and appropriate methods of contraception during the trial and until at least six months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another contraceptive method during the trial and until at least 6 months after the end of the study treatment,
16. Registration in a national health care system (CMU included for France).
Exclusion Criteria
2. Exclusive bone metastasis,
3. Uncontrolled hypercalcemia,
4. Pre-existing permanent neuropathy (NCI grade ≥2),
5. Uncontrolled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy,
6. Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
7. Treatment with any investigational medicinal product within 28 days prior to study entry,
8. Other serious and uncontrolled non-malignant disease,
9. Gilbert's syndrome,
10. Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for \>5 years,
11. Major surgery (open biopsy, surgical resection, wound revision or any other major surgery involving entry into body cavity) or significant traumatic injury within the last 28 days prior to randomization, and/or minor surgical procedure including placement of a vascular device within 2 days of first study treatment,
12. Pregnant or breastfeeding women,
13. Patients with known allergy/hypersensitivity to any component of study drugs,
14. History of arterial thrombo and/or embolic event (e.g. myocardial infarction, stroke,…) within 6 months prior to randomization,
15. Chronic inflammatory bowel disease
16. Total bowel obstruction,
17. History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to randomization,
18. Serious, non-healing wound, active ulcer or untreated bone fracture,
19. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding,
20. Current or recent (within 10 days of randomization) use of aspirin (\>325 mg/d), clopidogrel (\>75 mg/d) or use of oral anticoagulants or thrombolytic agents.
21. Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine
22. Concomitant administration of prophylactic phenytoin.
23. Treatment with sorivudine or its chemically related analogues, such as brivudine.
24. Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
25. Concomitant use with St John's Wort
26. Patients with interstitial pneumonitis or pulmonary fibrosis
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Responsible Party
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Principal Investigators
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Benoist Chibaudel, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Hospitalier Franco-Britannique
Locations
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Centre Hospitalier Annecy Gennevois
Annecy, , France
Centre hospitalier Auxerre
Auxerre, , France
Centre François Baclesse
Caen, , France
Centre Hospitalier
Cannes, , France
Centre Hospitalier Chateauroux
Châteauroux, , France
Hospices Civils de Colmar
Colmar, , France
Hôpital Henri Mondor
Créteil, , France
Centre Hospitalier
Dax, , France
Centre d'oncologie et de radiothérapie du Parc
Dijon, , France
Centre Georges François Leclerc
Dijon, , France
CHD Vendée
La Roche-sur-Yon, , France
Hôpital Louis Pasteur
Le Coudray, , France
Hôpital Privé de l'Estuaire
Le Havre, , France
Clinique Victor Hugo
Le Mans, , France
Institut d'oncoloige Hartmann
Levallois-Perret, , France
Institut Hospitalier Franco-Britannique
Levallois-Perret, , France
Centre Bourgogne
Lille, , France
Centre Hospitalier de Bretagne Sud
Lorient, , France
Hôpital Privé Jean Mermoz
Lyon, , France
Hôpital Européen
Marseille, , France
Hôpital Nord
Marseille, , France
Centre Hospitalier Layné
Mont-de-Marsan, , France
Centre d'oncologie de Gentilly
Nancy, , France
Centre Sainte Catherine de Sienne
Nantes, , France
Hôpital Cochin
Paris, , France
Hôpital Pitié-Salpêtrière
Paris, , France
Hôpital Saint-Antoine
Paris, , France
Hôpital Saint-Joseph
Paris, , France
Hôpital Saint-Louis
Paris, , France
Hôpital Tenon
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Hôpital Périgueux
Périgueux, , France
Clinique Armoricaine de Radiologie
Saint-Brieuc, , France
Clinique de l'Alliance
Saint-Cyr-sur-Loire, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
CH de Senlis
Senlis, , France
Centre Hospitalier de Sens
Sens, , France
Hôpital Broussais - CH Saint Malo
St-Malo, , France
Clinique Sainte-Anne
Strasbourg, , France
Hôpital Foch
Suresnes, , France
Hôpitaux du Léman
Thonon-les-Bains, , France
Hôpital Sainte Musse
Toulon, , France
Clinique Générale
Valence, , France
Institut de Cancérologie
Villeneuve-d'Ascq, , France
Bon Secours Hospital
Cork, , Ireland
Cork University Hospital
Cork, , Ireland
Adelaide & Meath Hospital Dublin ( AMNCH)
Dublin, , Ireland
Beaumont Hospital
Dublin, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
Mater Private Hospital
Dublin, , Ireland
St. James's Hospital
Dublin, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
University Hospital Waterford
Waterford, , Ireland
Sheba Tel Hashomer
Ramat Gan, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Countries
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References
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Chibaudel B, Bonnetain F, Tournigand C, de Larauze MH, de Gramont A, Laurent-Puig P, Paget J, Hadengue A, Notelet D, Benetkiewicz M, Andre T, de Gramont A. STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer. BMC Cancer. 2015 Jul 4;15:496. doi: 10.1186/s12885-015-1503-7.
Other Identifiers
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2013-001928-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
STRATEGIC-1 C12- 2
Identifier Type: -
Identifier Source: org_study_id
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