Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .

Colorectal Adenocarcinoma Clinical Trial

— REGOLD  

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 .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788006
• Other study ID #: FFCD 1404 - REGOLD
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: September 2017

Study information

• Verified date: July 2023
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinoma

Intervention

Drug:
• Regorafenib 160 mg

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

References & Publications (1)

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, Pamouk — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With a Tumoral Control Rate at 2 Months	Tumor control rate is defined as the percentage of patients with complete tumor response, partial tumor response, or tumor stability on regorafenib therapy at 2 months after initiation of therapy as determined by the investigator per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.1 criteria) for target lesions and assessed by CT-Scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stability : neither complete or partial response nor progression.	2 months after the start of treatment
Secondary	Overall Survival	Overall survival was defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news wastaken into account.; Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.	Up to approximatively 1 year after the end of the treatment