Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .
NCT ID: NCT02788006
Last Updated: 2024-02-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2016-01-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Regorafenib 160 mg
Regorafenib 160 mg
Interventions
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Regorafenib 160 mg
Eligibility Criteria
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Inclusion Criteria
* Measurable disease according RECIST 1.1
* Age ≥ 70 years
* ECOG ≤ 1
* Biological values Haemoglobin ≥ 9 g/dL, PNN ≥ 1500/mm3, platelets≥ 100 000/mm3, bilirubin ≤ 1,5N, ASAT, ALAT et PAL ≤ 2,5N (≤ 5N if hepatic metastases), lipase ≤1,5N, TP≥ 70%, Creatinine clairance ≥ 30 mL/min
* Patient without response to 5FU chemotherapy or anti-vegf treatment or anti EGFR treatment (if RAS wild-type), in progression during this treatment or treatment stopped because of toxicities
* Geriatric Questionnaires answered
* Life-expectancy ≥ 3 months
* Informed Consent Signed
Exclusion Criteria
* Previous treatment with regorafenib or other multikinase treatment
* Other cancer during the last 5 years, excepted in-situ cervix cancer, skin cancer non melanoma and cancer of the bladder curatively treated
* Radiotherapy: with extended fields in the last 4 weeks, with limited fields in the last 2 weeks previous inclusion
* Toxicity \> grade 1 not resolved with previous treatment
* Major surgery in the 28 days before the inclusion
* Non cicatrized injury, ulcer or bone fracture
* Congestive Cardiac insufficiency classe \>2 (NYHA)
* Unstable angor in the last 3 months
* Myocardial Infraction in the 6 months before inclusion
* HTA not controlled
* Pheochromocytome
* Arterial or venous thromboembolism in the past 6 months
* Infection of grade \> 2
* VIH infection
* B or C hepatitis necessiting a specific treatment
* Cirrhosis
* Suspicion of brain metastasis or brain metastasis
* Haemorraghe ofgrade \>3 in the last weeks
* Symptomatic Pulmonary fibrosis
* Proteinuria \> grade 3
* Malabsorption
* Allergy know to the treatment or to one similar treatment or to one treatment component
* Systemic anti-cancer drug during the study or the the last 4 weeks
* Concomitant treatment with CYP3A4 inhibitor or inductor or with UGT1A9 inhibitor
* Social, psychological or medical condition which can interfere with the study participation
70 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Thomas APARICIO, Pr
Role: PRINCIPAL_INVESTIGATOR
Hôpital Avicenne BOBIGNY
Locations
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CH Victor Dupouy
Argenteuil, , France
Centre François Bacless
Caen, , France
Centre Oncologie et Radiothérapie
Dijon, , France
Clinique du Cap d'Or
La Seyne-sur-Mer, , France
Caluire et Cuire - Infirmerie Protestante de Lyon
Lyon, , France
CH Lyon Sud (HCL) - Pierre Benite
Lyon, , France
Hôpital privé Jean Mermoz
Lyon, , France
Hôpital Européen
Marseille, , France
CHRU - Hôpital Saint Eloi
Montpellier, , France
CHR - Service HGE
Orléans, , France
Saint Joseph
Paris, , France
CH
Perpignan, , France
Hôpital Haut Leveque
Pessac, , France
CH Annecy Genevois
Pringy, , France
Centre Paul Strauss
Strasbourg, , France
Hôpital privé
Villeneuve-d'Ascq, , France
Countries
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References
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Aparicio T, Darut-Jouve A, Khemissa Akouz F, Monterymard C, Artru P, Cany L, Romano O, Valenza B, Le Foll C, Delbaldo C, Falandry C, Norguet Monnereau E, Ben Abdelghani M, Smith D, Rinaldi Y, Pere Verge D, Baize N, Maillard E, Dohan A, Des Guetz G, Pamoukdjian F, Lepage C. Single-arm phase II trial to evaluate efficacy and tolerance of regorafenib monotherapy in patients over 70 with previously treated metastatic colorectal adenocarcinoma FFCD 1404 - REGOLD. J Geriatr Oncol. 2020 Nov;11(8):1255-1262. doi: 10.1016/j.jgo.2020.04.001. Epub 2020 Apr 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FFCD 1404 - REGOLD
Identifier Type: -
Identifier Source: org_study_id
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