Colorectal Cancer With Non Resectable Hepatic MetastasisPhase 2NCT01839877
Intra-arterial Hepatic Beads Loaded With Irinotecan With Concomitant Chemotherapy With FOLFOX in Patients With Colorectal Cancer With Unresectable Liver Metastases: a Phase II Multicenter Study
A Phase 2 study testing HIA DEBIRI + systemic FOLFOX in people with Colorectal Cancer With Non Resectable Hepatic Metastasis, run by Federation Francophone de Cancerologie Digestive at 9 sites in France.
Trial summary
Treatment of patients with colorectal cancer having liver metastases is currently based on systemic chemotherapy. Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of response and secondary resectability, however it is particularly toxic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer With Non Resectable Hepatic Metastasis
- What is being tested?
- HIA DEBIRI + systemic FOLFOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 9 sitesFrance
- Study dates
- May 2013to Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven colorectal adenocarcinoma,
- Liver metastases radiologically or histologically proven
- At least one measurable liver lesions by RECIST v1.1
- Age ≥ 18 years
- WHO Index < or = 2
- Life expectancy ≥ 3 months
Show all 16Show fewer
- No extrahepatic disease except lung nodules if number < or = 3 and size < 10 mm each
- Healthy liver <60%
- Primary tumor resected or still in place
- No prior chemotherapy for metastases treatment (except a perioperative chemotherapy, if the last cycle was administered at least 12 months ago)
- Adjuvant chemotherapy after resection of the primary authorized if the last cycle was administered at least 12 months ago
- Normal hepatic function: total bilirubin ≤ 1.5 N; AST ≤ 5N; ALT ≤ 5N and PAL ≤ 5N
- TP ≥ 60%
- Adequate hematologic function: ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, Hb ≥ 9g/dl
- Good renal function: creatinine clearance ≥ 60 mL / min
- No cardiac dysfunction: no cardiovascular events in the last 6 months or no NYHA ≥ 2
Who cannot join
- Patient eligible for curative treatment (resection and / or radiofrequency ablation) by a multidisciplinary decision (including the opinion of a liver surgeon)
- Pregnant or lactating woman or patients of both sexes and of childbearing age not using adequate contraception
- History of cancer, except skin cancer (other than melanoma), carcinoma in situ of the cervix uteri treated curative. Other cancers treated with curative intent are permitted provided they did not relapse over the last 5 years
- Peripheral neuropathy
- Inflammatory Bowel Diseases
- Intestinal obstruction
Show all 15Show fewer
- Chronic liver disease (viral, alcoholic or metabolic)
- Immune Deficiency Syndromes (history of transplantation, infection with HIV)
- Known to have contraindications to 5FU, oxaliplatin, folinic acid, irinotecan or to contrast products
- Patients with known contraindications against hepatic embolization procedures:
- Presence of biliary-digestive anastomosis or biliary stent Cruoric or tumor thrombosis of the portal vein
- Patient who for psychological, social, family or geographical reasons could not be followed up regularly
- Legal disability (persons deprived of liberty or under guardianship)
- Patient is not affiliated to a social security scheme
- Participation in another concurrent study investigating the effect of treatment and this until 4 weeks after the end of the concurrent study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hopital Saint André
Bordeaux, 33075
CHU - Hôpital François Mitterand
Dijon
Hôpital Prive Jean Mermoz
Lyon, 69008
Centre Léon Berard
Lyon, 69373
Institut Paoli Calmette
Marseille, 13273
CHU de la TIMONE
Marseille, 13385
Hôpital Europeen G Pompidou
Paris, 75015
CHU Charles Nicolle
Rouen, 76031
Hôpital Rangueil
Toulouse, 31059
About this study
Treatment of patients with colorectal cancer having liver metastases is currently based on systemic chemotherapy.
Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of response and secondary resectability, however it is particularly toxic.
Read more
Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up and reserved for experienced centers.
The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to 2 sessions, and therefore could be more easily generalized.
- Being tested
- HIA DEBIRI + systemic FOLFOX
- Keywords
- Metastatic colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIA DEBIRI + systemic FOLFOXDrug
| Study group | Role | What they receive |
|---|---|---|
| HIA DEBIRI + systemic FOLFOX | Experimental | Intra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX Receives: Drug: HIA DEBIRI + systemic FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival Rate at 9 Months
The primary endpoint was to evaluate the rate of patients alive without progression at 9 months after the start of treatment. Events to be considered for the endpoint were:
- Progression : defined as radiological progression according to RECIST V1.1 criteria, as assessed by the investigator.
- Death Patients who progressed or died (from any cause) within 9 months of starting treatment were considered as failure for the primary endpoint. The first event which occured will be taken into accoun
Measured: at 9 months after inclusion
Secondary outcomes (1)
Overall Survival
It was defined as the time interval between the date of inclusion and the date of death (whatever the cause). Patients lost to follow-up or alive at the time of analysis were censored at the date of last news.
Measured: up to 4 years after patient's inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2017
- Study completionJan 2019
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 Cancer With Non Resectable Hepatic MetastasisStudies 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Responsible party
- Sponsor
- Investigators
- Julien TAIEB, Pr, Principal investigator, Fédération Francophone de Cancérologie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839877
- Sponsor's protocol ID
- FFCD 1201 DEBIRI
- Status last verified
- Jul 2024
- First submitted
- 12 Apr 2013
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pernot S, Pellerin O, Artru P, Monterymard C, Smith D, Raoul JL, De La Fouchardiere C, Dahan L, Guimbaud R, Sefrioui D, Jouve JL, Lepage C, Tougeron D, Taieb J; for FFCD1201-DEBIRI investigators/Collaborators. Intra-arterial hepatic beads loaded with irinotecan (DEBIRI) with mFOLFOX6 in unresectable liver metastases from colorectal cancer: a Phase 2 study. Br J Cancer. 2020 Aug;123(4):518-524. doi: 10.1038/s41416-020-0917-4. Epub 2020 Jun 8.
PubMed 32507854
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Hepatic Beads Loaded With Irinotecan With Concomitant Chemotherapy With FOLFOX in Patients With Colorectal Cancer With Unresectable Liver Metastases: a Phase II Multicenter Study
- ClinicalTrials.gov ID
- NCT01839877
- Acronym / sponsor ID
- FFCD 1201 DEBIRI
- Keywords
- Metastatic colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of patients with colorectal cancer having liver metastases is currently based on systemic chemotherapy.
Triple therapy with 5FU, oxaliplatin and irinotecan intravenously was effective in terms of response and secondary resectability, however it is particularly toxic.
Hepatic intra-arterial chemotherapy (HIA) has been the subject of several studies. It has shown good efficacy with oxaliplatin and FUDR. However, the procedure is difficult to set up and reserved for experienced centers.
The objective of this protocol is to use a triple therapy based on 5FU and oxaliplatin associated to irinotecan which is administered by hepatic intra-arterial route, loaded onto microbeads (DEBIRI). Furthermore, the procedure for chemo-embolization DEBIRI is limited to 2 sessions, and therefore could be more easily generalized.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIA DEBIRI + systemic FOLFOX | Experimental | Drug: HIA DEBIRI + systemic FOLFOXIntra-arterial hepatic beads loaded with irinotecan with systemic FOLFOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically proven colorectal adenocarcinoma,
- Liver metastases radiologically or histologically proven
- At least one measurable liver lesions by RECIST v1.1
- Age ≥ 18 years
- WHO Index < or = 2
Key exclusion criteria (15 listed)
- Patient eligible for curative treatment (resection and / or radiofrequency ablation) by a multidisciplinary decision (including the opinion of a liver surgeon)
- Pregnant or lactating woman or patients of both sexes and of childbearing age not using adequate contraception
- History of cancer, except skin cancer (other than melanoma), carcinoma in situ of the cervix uteri treated curative. Other cancers treated with curative intent are permitted provided they did not relapse over the last 5 years
- Peripheral neuropathy
- Inflammatory Bowel Diseases
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 |
|---|---|---|
| HIA DEBIRI + systemic FOLFOX | Drug | HIA DEBIRI + systemic FOLFOX |
Primary outcome
Progression-free Survival Rate at 9 Months
Time frame: at 9 months after inclusion
The primary endpoint was to evaluate the rate of patients alive without progression at 9 months after the start of treatment. Events to be considered for the endpoint were: * Progression : defined as radiological progression according to RECIST V1.1 criteria, as assessed by the investigator. * Death Patients who progressed or died (from any cause) within 9 months of starting treatment were considered as failure for the primary endpoint. The first event which occured will be taken into accoun
1 secondary outcome
Overall Survival
Time frame: up to 4 years after patient's inclusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32507854Pernot S, Pellerin O, Artru P, Monterymard C, Smith D, Raoul JL, De La Fouchardiere C, Dahan L, Guimbaud R, Sefrioui D, Jouve JL, Lepage C, Tougeron D, Taieb J; for FFCD1201-DEBIRI investigators/Collaborators. Intra-arterial hepatic beads loaded with irinotecan (DEBIRI) with mFOLFOX6 in unresectable liver metastases from colorectal cancer: a Phase 2 study. Br J Cancer. 2020 Aug;123(4):518-524. doi: 10.1038/s41416-020-0917-4. Epub 2020 Jun 8.
Related trials for Colorectal Cancer With Non Resectable Hepatic Metastasis
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
Recruiting
TheraSphere Japan Pre-Market Study
Liver Neoplasms
RecruitingPhase 2
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Metastatic Colorectal Cancer (Mcrc), Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruiting
Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases
Colorectal Cancer, Liver Metastases
RecruitingPhase 3
Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver
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.
Julien TAIEB, Pr principal investigator
Fédération Francophone de Cancérologie Digestive
9 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 HIA DEBIRI + systemic FOLFOX in people with Colorectal Cancer With Non Resectable Hepatic Metastasis, run by Federation Francophone de Cancerologie Digestive at 9 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 16 inclusion and 15 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 8 Oct 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?
Progression-free Survival Rate at 9 Months (time frame: at 9 months after inclusion). 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 NCT01839877, 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 8 Oct 2024.