Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .
REGOLD
Phase II Study Evaluating the Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years Old With a Metastatic Colorectal Adenocarcinoma .
1 other identifier
interventional
43
1 country
16
Brief Summary
Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2016
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
February 23, 2024
CompletedFebruary 23, 2024
July 1, 2023
1.6 years
May 20, 2016
June 24, 2022
July 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Overall Survival
Up to approximatively 1 year after the end of the treatment
Study Arms (1)
Regorafenib 160 mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Toxicity \> grade 1 not resolved with previous treatment
- Non cicatrized injury, ulcer or bone fracture
- Congestive Cardiac insufficiency classe \>2 (NYHA)
- Unstable angor in the last 3 months
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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
Related 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, 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.
PMID: 32334940RESULT
MeSH Terms
Interventions
Results Point of Contact
- Title
- Karine Le Malicot
- Organization
- Fédération Francophone de Cancérologie Digestive
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas APARICIO, Pr
Hôpital Avicenne BOBIGNY
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2016
First Posted
June 2, 2016
Study Start
January 1, 2016
Primary Completion
August 1, 2017
Study Completion
September 1, 2017
Last Updated
February 23, 2024
Results First Posted
February 23, 2024
Record last verified: 2023-07