Colon Cancer Liver MetastasisTACETUXNCT01891552
Observational Study on Second Line Treatment of Liver Metastases With DEBIRI and Cetuximab
An observational study of Colon Cancer Liver Metastasis, run by International Group of Endovascular Oncology at 1 site in Italy.
Trial summary
The recently introduced chemoembolization has been considered to be a very attractive new method in terms of response in the treatment of liver metastases from colon cancer carcinoma (LM-CRC). It appears to be particularly useful if carried out with the new embolization materials. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colon Cancer Liver Metastasis
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to May 2015
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Unresectable hepatic metastases from colorectal carcinoma (CRC-LM)
- Progression of disease after first line therapy containing Irinotecan completed at least one month previously
- Performance status (PS) 0-2
- Biochemistry parameters within normal limits (ALT and gamma glutamyl transpeptidase not exceeding three times the upper limit of normal, total bilirubin not exceeding 2.5 mg/ml)
- Adequate information and subsequent written informed consent
- Life expectancy > 3 months
- Patients K-RAS wild type
Who cannot join
- Extension of disease greater than 50% of the parenchymal liver (confirmed by CAT scan or MRI)
- Brain metastases
- Severe and confirmed vascular diseases
- Other concomitant malignancies except for cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix
- Evidence of significant diseases such as uncontrolled diabetes, congestive heart failure, chronic renal insufficiency (CRI)
- Known hypersensitivity reactions towards components of the study drugs
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- Pregnant or breastfeeding women or women of childbearing potential not making use of effective contraceptives
- Family, psychological, social or geographical circumstances preventing the patient from undergoing follow-up and from complying with protocol procedures
- Patients K-RAS mutant
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore
Pesaro, PU, 61122
About this study
Official title: Observational Study on Second Line Treatment of Colorectal Liver Metastases (KRas wt) by Hepatic Intra-arterial Chemoembolization With Dc Beads 70-150 μm Microspheres Preloaded With Irinotecan 200 Mgr Plus Systemic Cetuximab
- The recently introduced chemoembolization has been considered to be a very attractive new method in terms of response in the treatment of liver metastases from colon cancer carcinoma (LM-CRC). It appears to be particularly useful if carried out with the new embolization materials.
- An 80% response rate was reported using TACE with Irinotecan pre-loaded Beads in patients with liver metastases from colon cancer, who had been pretreated with 2 or more lines of chemotherapy.
- Since a greater activity was attained by a combination of Cetuximab and Irinotecan versus Cetuximab in monotherapy, the European Agency for the Evaluation of Medicinal Products (EMEA) has granted authorization to the use of Cetuximab in association with irinotecan in the treatment of irinotecan-refractory CRC-LM.
- In this study we want to collect data on on time to progression and tolerability using DEBIRI+Cetuximab in LM-CRC
Read the detailed description
This is an observational study and the treatment is related to the experiences and economical availability of each center.
Primary objective: To collect data on time to progression (local and/or distant progression) after administration of Dc-Beads microspheres preloaded with Irinotecan 200 mgr via hepatic intra-arterial locoregional delivery (TACE) in/without association with standard weekly therapy with Cetuximab.
Secondary objectives: To collect data on tolerability of treatment and improvement of quality of life (Edmonton Symptom Assessment System (ESAS))
Treatment under observation :
Program A ( for all patients)
Day +1:
Lobar Infusion (lobe with dominant disease) of Irinotecan 100 mg preloaded into 2 ml of 70-150 µm M1 microspheres.
Second lobar infusion of Irinotecan 100 mg preloaded into 2 ml of 70-150 µm M1 microspheres can be administered at the same time contralaterally or in a further TACE.
Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated
Program B ( for Centers in which Cetuximab is available) 5.2 Cetuximab administered as per standard scheme: Day -15: loading dose with 400 mg/mq i.v. over a 2-hour period Day +21 and subsequent weekly administrations: 250 mg/mq i.v. over a one hour period.
It is pointed out that administration of Cetuximab will be continued following the timeline of the first infusion relative to the intra-arterial administration.
Evaluation of response
Response must be assessed by repeating the following examinations at Day 30, Day 90 and Day 120 after start of treatment:
Chest-abdomen CAT scan with and without contrast medium (refer to Section 4). Evaluation will be based on the Response Evaluation Criteria In Solid Tumors (RECIST) cancer markers (CEA, Carbohydrate Antigen (CA) 19.9)
Assessment of quality of life The Edmonton Symptom Assessment System (ESAS) is used to monitor health conditions and quality of life.
The questionnaire must be filled in by the patient unaided by family members or by health care personnel, over a period of about 15 minutes. Assessment of quality of life will be performed during the baseline visit and at Day 30, Day 60 and Day 120 from start of treatment.
It is important for the questionnaire to be completed by the patient before undergoing the physical examination, in other words before discussing with the physician about any examinations which might give an indication of the favorable or unfavorable course of the disease. In providing the questionnaire to the patient, the physician will explain how to complete it without discussing the contents of the questions, and once the patient has completed the questionnaire, the physician will check that all questions have been answered.
- Conditions
- Colon Cancer Liver Metastasis
- Keywords
- Colon Cancer, Liver Metastasis, DEBIRI, cetuximab, efficacy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tacetux | DEBIRI+ CETUXIMAB ADMINISTRATION | |
| DEBIRI | only DEBIRI treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to progression
Measured: one year
Secondary outcomes (1)
number of adverse events
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon Cancer Liver 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- International Group of Endovascular Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giammaria Fiorentini, International Group of Endovascular Oncology
- Investigators
- GIAMMARIA FIORENTINI, MD, Principal investigator, International Group of Endovascular Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891552
- Sponsor's protocol ID
- TACETUX01
- Acronym
- TACETUX
- Status last verified
- May 2015
- First submitted
- 26 Jun 2013
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fiorentini G, Aliberti C, Tilli M, Mulazzani L, Graziano F, Giordani P, Mambrini A, Montagnani F, Alessandroni P, Catalano V, Coschiera P. Intra-arterial infusion of irinotecan-loaded drug-eluting beads (DEBIRI) versus intravenous therapy (FOLFIRI) for hepatic metastases from colorectal cancer: final results of a phase III study. Anticancer Res. 2012 Apr;32(4):1387-95.
PubMed 22493375Guadagni S, Fiorentini G, Clementi M, Palumbo P, Mambrini A, Masedu F. Mitomycin C hypoxic pelvic perfusion for unresectable recurrent rectal cancer: pharmacokinetic comparison of surgical and percutaneous techniques. Updates Surg. 2017 Sep;69(3):403-410. doi: 10.1007/s13304-017-0480-6. Epub 2017 Aug 8.
PubMed 28791628
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Second Line Treatment of Colorectal Liver Metastases (KRas wt) by Hepatic Intra-arterial Chemoembolization With Dc Beads 70-150 μm Microspheres Preloaded With Irinotecan 200 Mgr Plus Systemic Cetuximab
- ClinicalTrials.gov ID
- NCT01891552
- Acronym / sponsor ID
- TACETUX / TACETUX01
- Conditions
- Colon Cancer Liver Metastasis
- Keywords
- Colon Cancer, Liver Metastasis, DEBIRI, cetuximab, efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- International Group of Endovascular OncologyUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The recently introduced chemoembolization has been considered to be a very attractive new method in terms of response in the treatment of liver metastases from colon cancer carcinoma (LM-CRC). It appears to be particularly useful if carried out with the new embolization materials.
- An 80% response rate was reported using TACE with Irinotecan pre-loaded Beads in patients with liver metastases from colon cancer, who had been pretreated with 2 or more lines of chemotherapy.
- Since a greater activity was attained by a combination of Cetuximab and Irinotecan versus Cetuximab in monotherapy, the European Agency for the Evaluation of Medicinal Products (EMEA) has granted authorization to the use of Cetuximab in association with irinotecan in the treatment of irinotecan-refractory CRC-LM.
- In this study we want to collect data on on time to progression and tolerability using DEBIRI+Cetuximab in LM-CRC
Detailed description
This is an observational study and the treatment is related to the experiences and economical availability of each center.
Primary objective: To collect data on time to progression (local and/or distant progression) after administration of Dc-Beads microspheres preloaded with Irinotecan 200 mgr via hepatic intra-arterial locoregional delivery (TACE) in/without association with standard weekly therapy with Cetuximab.
Secondary objectives: To collect data on tolerability of treatment and improvement of quality of life (Edmonton Symptom Assessment System (ESAS))
Treatment under observation :
Program A ( for all patients)
Day +1:
Lobar Infusion (lobe with dominant disease) of Irinotecan 100 mg preloaded into 2 ml of 70-150 µm M1 microspheres.
Second lobar infusion of Irinotecan 100 mg preloaded into 2 ml of 70-150 µm M1 microspheres can be administered at the same time contralaterally or in a further TACE.
Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated
Program B ( for Centers in which Cetuximab is available) 5.2 Cetuximab administered as per standard scheme: Day -15: loading dose with 400 mg/mq i.v. over a 2-hour period Day +21 and subsequent weekly administrations: 250 mg/mq i.v. over a one hour period.
It is pointed out that administration of Cetuximab will be continued following the timeline of the first infusion relative to the intra-arterial administration.
Evaluation of response
Response must be assessed by repeating the following examinations at Day 30, Day 90 and Day 120 after start of treatment:
Chest-abdomen CAT scan with and without contrast medium (refer to Section 4). Evaluation will be based on the Response Evaluation Criteria In Solid Tumors (RECIST) cancer markers (CEA, Carbohydrate Antigen (CA) 19.9)
Assessment of quality of life The Edmonton Symptom Assessment System (ESAS) is used to monitor health conditions and quality of life.
The questionnaire must be filled in by the patient unaided by family members or by health care personnel, over a period of about 15 minutes. Assessment of quality of life will be performed during the baseline visit and at Day 30, Day 60 and Day 120 from start of treatment.
It is important for the questionnaire to be completed by the patient before undergoing the physical examination, in other words before discussing with the physician about any examinations which might give an indication of the favorable or unfavorable course of the disease. In providing the questionnaire to the patient, the physician will explain how to complete it without discussing the contents of the questions, and once the patient has completed the questionnaire, the physician will check that all questions have been answered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacetux | – | –DEBIRI+ CETUXIMAB ADMINISTRATION |
| DEBIRI | – | –only DEBIRI treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (7 listed)
- Unresectable hepatic metastases from colorectal carcinoma (CRC-LM)
- Progression of disease after first line therapy containing Irinotecan completed at least one month previously
- Performance status (PS) 0-2
- Biochemistry parameters within normal limits (ALT and gamma glutamyl transpeptidase not exceeding three times the upper limit of normal, total bilirubin not exceeding 2.5 mg/ml)
- Adequate information and subsequent written informed consent
Key exclusion criteria (9 listed)
- Extension of disease greater than 50% of the parenchymal liver (confirmed by CAT scan or MRI)
- Brain metastases
- Severe and confirmed vascular diseases
- Other concomitant malignancies except for cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix
- Evidence of significant diseases such as uncontrolled diabetes, congestive heart failure, chronic renal insufficiency (CRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time to progression
Time frame: one year
1 secondary outcome
number of adverse events
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
- Results publication: PubMed 22493375Fiorentini G, Aliberti C, Tilli M, Mulazzani L, Graziano F, Giordani P, Mambrini A, Montagnani F, Alessandroni P, Catalano V, Coschiera P. Intra-arterial infusion of irinotecan-loaded drug-eluting beads (DEBIRI) versus intravenous therapy (FOLFIRI) for hepatic metastases from colorectal cancer: final results of a phase III study. Anticancer Res. 2012 Apr;32(4):1387-95.
- Derived from this study: PubMed 28791628Guadagni S, Fiorentini G, Clementi M, Palumbo P, Mambrini A, Masedu F. Mitomycin C hypoxic pelvic perfusion for unresectable recurrent rectal cancer: pharmacokinetic comparison of surgical and percutaneous techniques. Updates Surg. 2017 Sep;69(3):403-410. doi: 10.1007/s13304-017-0480-6. Epub 2017 Aug 8.
- International group of endovascular oncology (IGEVO) websiteLink provided by the sponsor.
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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.
GIAMMARIA FIORENTINI, MD principal investigator
International Group of Endovascular Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer Liver Metastasis, run by International Group of Endovascular Oncology at 1 site in Italy.
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 7 inclusion and 9 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 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to progression (time frame: one year). 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 NCT01891552, which also lists 2 linked publications.
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 13 May 2015.