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

Primary Purpose

Colorectal Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Regorafenib 160 mg
Sponsored by
Federation Francophone de Cancerologie Digestive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Adenocarcinoma

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH Victor Dupouy
  • Centre François Bacless
  • Centre Oncologie et Radiothérapie
  • Clinique du Cap d'Or
  • Caluire et Cuire - Infirmerie Protestante de Lyon
  • CH Lyon Sud (HCL) - Pierre Benite
  • Hôpital privé Jean Mermoz
  • Hôpital Européen
  • CHRU - Hôpital Saint Eloi
  • CHR - Service HGE
  • Saint Joseph
  • CH
  • Hôpital Haut Leveque
  • CH Annecy Genevois
  • Centre Paul Strauss
  • Hôpital privé

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Regorafenib 160 mg

Arm Description

Outcomes

Primary Outcome Measures

Tumor control rate
Number of patients with a complete or partial response or in stability 2 months after the beginning of treatment

Secondary Outcome Measures

Full Information

First Posted
May 20, 2016
Last Updated
December 21, 2020
Sponsor
Federation Francophone de Cancerologie Digestive
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1. Study Identification

Unique Protocol Identification Number
NCT02788006
Brief Title
Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .
Acronym
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 .
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regorafenib 160 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Regorafenib 160 mg
Primary Outcome Measure Information:
Title
Tumor control rate
Description
Number of patients with a complete or partial response or in stability 2 months after the beginning of treatment
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas APARICIO, Pr
Organizational Affiliation
Hôpital Avicenne BOBIGNY
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Victor Dupouy
City
Argenteuil
Country
France
Facility Name
Centre François Bacless
City
Caen
Country
France
Facility Name
Centre Oncologie et Radiothérapie
City
Dijon
Country
France
Facility Name
Clinique du Cap d'Or
City
La Seyne Sur Mer
Country
France
Facility Name
Caluire et Cuire - Infirmerie Protestante de Lyon
City
Lyon
Country
France
Facility Name
CH Lyon Sud (HCL) - Pierre Benite
City
Lyon
Country
France
Facility Name
Hôpital privé Jean Mermoz
City
Lyon
Country
France
Facility Name
Hôpital Européen
City
Marseille
Country
France
Facility Name
CHRU - Hôpital Saint Eloi
City
Montpellier
Country
France
Facility Name
CHR - Service HGE
City
Orléans
Country
France
Facility Name
Saint Joseph
City
Paris
Country
France
Facility Name
CH
City
Perpignan
Country
France
Facility Name
Hôpital Haut Leveque
City
Pessac
Country
France
Facility Name
CH Annecy Genevois
City
Pringy
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Facility Name
Hôpital privé
City
Villeneuve D'Ascq
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32334940
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.
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Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .

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