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

July 11, 2023 updated by: Federation Francophone de Cancerologie Digestive

Phase II Study Evaluating the Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years Old With a Metastatic Colorectal Adenocarcinoma .

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France
        • CH Victor Dupouy
      • Caen, France
        • Centre François Bacless
      • Dijon, France
        • Centre Oncologie et Radiothérapie
      • La Seyne Sur Mer, France
        • Clinique du Cap d'Or
      • Lyon, France
        • Caluire et Cuire - Infirmerie Protestante de Lyon
      • Lyon, France
        • CH Lyon Sud (HCL) - Pierre Benite
      • Lyon, France
        • Hopital Prive Jean Mermoz
      • Marseille, France
        • Hôpital Européen
      • Montpellier, France
        • CHRU - Hôpital Saint Eloi
      • Orléans, France
        • CHR - Service HGE
      • Paris, France
        • Saint Joseph
      • Perpignan, France
        • CH
      • Pessac, France
        • Hôpital Haut Lévêque
      • Pringy, France
        • CH Annecy Genevois
      • Strasbourg, France
        • Centre Paul Strauss
      • Villeneuve D'Ascq, France
        • Hôpital privé

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regorafenib 160 mg
Drug: Regorafenib 160 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With a Tumoral Control Rate at 2 Months
Time Frame: 2 months after the start of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to approximatively 1 year after the end of the treatment

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Investigators

  • Principal Investigator: Thomas APARICIO, Pr, Hôpital Avicenne BOBIGNY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimated)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFCD 1404 - REGOLD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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