Clinical trial NCT02788006: Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .
Official title: Phase II Study Evaluating the Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years Old With a Metastatic Colorectal Adenocarcinoma .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Adenocarcinoma
Lead sponsor: Federation Francophone de Cancerologie Digestive
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 43
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer


Eligibility criteria: Inclusion Criteria:

* Metastatic colorectal cancer with histological proof
* 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:

* Not able to swallow tablets (crushed tablets are not allowed)
* 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

Primary outcomes:
measure: Percentage of Patients With a Tumoral Control Rate at 2 Months
timeFrame: 2 months after the start of treatment
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to approximatively 1 year after the end of the treatment
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: Caen
country: France
facility: Centre François Bacless
city: Dijon
country: France
facility: Centre Oncologie et Radiothérapie
city: La Seyne Sur Mer
country: France
facility: Clinique du Cap d'Or
city: Lyon
country: France
facility: Caluire et Cuire - Infirmerie Protestante de Lyon
city: Lyon
country: France
facility: CH Lyon Sud (HCL) - Pierre Benite
city: Lyon
country: France
facility: Hôpital privé Jean Mermoz
city: Marseille
country: France
facility: Hôpital Européen
city: Montpellier
country: France
facility: CHRU - Hôpital Saint Eloi
city: Orléans
country: France
facility: CHR - Service HGE
city: Paris
country: France
facility: Saint Joseph
city: Perpignan
country: France
facility: CH
city: Pessac
country: France
facility: Hôpital Haut Leveque
city: Pringy
country: France
facility: CH Annecy Genevois
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Villeneuve D'Ascq
country: France
facility: Hôpital privé
Study officials:
affiliation: Hôpital Avicenne BOBIGNY
name: Thomas APARICIO, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.