Colorectal AdenocarcinomaPhase 2REGOLDNCT02788006
Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .
A Phase 2 study testing Regorafenib 160 mg in people with Colorectal Adenocarcinoma, run by Federation Francophone de Cancerologie Digestive at 16 sites in France.
Trial summary
Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma
- What is being tested?
- Regorafenib 160 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 16 sitesFrance
- Study dates
- Jan 2016to Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- Geriatric Questionnaires answered
- Life-expectancy ≥ 3 months
- Informed Consent Signed
Who cannot join
- 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
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- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
CH Victor Dupouy
Argenteuil
Centre François Bacless
Caen
Centre Oncologie et Radiothérapie
Dijon
Clinique du Cap d'Or
La Seyne-sur-Mer
Caluire et Cuire - Infirmerie Protestante de Lyon
Lyon
CH Lyon Sud (HCL) - Pierre Benite
Lyon
Hôpital privé Jean Mermoz
Lyon
Hôpital Européen
Marseille
CHRU - Hôpital Saint Eloi
Montpellier
CHR - Service HGE
Orléans
Saint Joseph
Paris
CH
Perpignan
Hôpital Haut Leveque
Pessac
CH Annecy Genevois
Pringy
Centre Paul Strauss
Strasbourg
Hôpital privé
Villeneuve-d'Ascq
About this study
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 .
Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer
- Conditions
- Colorectal Adenocarcinoma
- Being tested
- Regorafenib 160 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib 160 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib 160 mg | Experimental | Not described Receives: Drug: Regorafenib 160 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months after the start of treatment
Secondary outcomes (1)
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.
Measured: Up to approximatively 1 year after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas APARICIO, Pr, Principal investigator, Hôpital Avicenne BOBIGNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788006
- Sponsor's protocol ID
- FFCD 1404 - REGOLD
- Acronym
- REGOLD
- Status last verified
- Jul 2023
- First submitted
- 20 May 2016
- Last updated
- 23 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32334940
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 .
- ClinicalTrials.gov ID
- NCT02788006
- Acronym / sponsor ID
- REGOLD / FFCD 1404 - REGOLD
- Conditions
- Colorectal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Posted 23 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regorafenib 160 mg | Experimental | Drug: Regorafenib 160 mg |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regorafenib 160 mg | Drug | Regorafenib 160 mg |
Primary outcome
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.
1 secondary outcome
Overall Survival
Time frame: Up to approximatively 1 year after the end of the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32334940Aparicio 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas APARICIO, Pr principal investigator
Hôpital Avicenne BOBIGNY
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Regorafenib 160 mg in people with Colorectal Adenocarcinoma, run by Federation Francophone de Cancerologie Digestive at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With a Tumoral Control Rate at 2 Months (time frame: 2 months after the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.