CholangiocarcinomaPhase 2MispheCNCT01912053
Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma
A Phase 2 study testing Therasphere® in association with Gemcitabine and Cisplatin in people with Cholangiocarcinoma, run by Center Eugene Marquis at 7 sites in France.
Trial summary
The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Therasphere® in association with Gemcitabine and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 7 sitesFrance
- Study dates
- Sep 2013to Nov 2017
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed intra-hepatic cholangiocarcinoma.
- Measurable target of at least 2 cm diameter.
- Healthy liver or cirrhosis CHILD < B8.
- WHO-PS: 0-1.
- Age ≥ 18 years.
- Non-Metastatic disease in extra-hepatic (are permitted: local lymph nodes < 3 cm, less than 5 lung nodes < 11 mm).
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- Creatinine clearance (calculated with Cockcroft and Gault formula) ≥ 55 ml/min, polymorphonuclear neutrophils ≥ 1500 G/L, platelets ≥ 80 G/L, prothrombin ≥ 40% (INR ≤ 2.3), serum albumin ≥ 28 g/l, serum bilirubin ≤ 3 x LSN.
- Pregnancy test: negative for women of childbearing potential.
- Reliable contraception for a childbearing couple, men and woman must have an reliable contraception during the treatment and until 6 months following the end of the treatment by chemotherapy
- Signed informed consent form.
- Patient with national health insurance.
Who cannot join
- Pancreas cancer or duodenum cancer invading the bile duct or ampullary cancer. Cholangiocarcinoma of the bile ducts: hilar, main duct, gallbladder.
- Extra-hepatic metastasis (including local lymph nodes measuring > 30 mm).
- Primary sclerosing cholangitis.
- History of chemoembolization or radioembolization.
- Cirrhose CHILD > B7
- Portal vein trunk tumoral thrombosis
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- History of hepato-biliary neo adjuvant or palliative chemotherapy and/or radiotherapy.
- Contra indication of Gemcitabine and/or Cisplatin.
- Other invasive active cancer, excepting in situ cervical cancer and basocellular or spino cellular skin cancer treated adequately. Any history of cancer not considered as completely cured for at least one year.
- Technical failure of the diagnostic arteriography.
- Extra hepatic uptake on the pre-therapeutic scintigraphy not manageable with an arteriography.
- Dosimetry study predicting lung exposure > 30 Gy.
- Any unstable medical history (diabetes, hypertension …).
- History of organ transplant.
- Symptomatic grade 1 angina pectoris or grade ≥ 2 angina pectoris.
- An evolutive neuropathy.
- Patient who already has been involved in a clinical trial with drug intake, whether this drug was experimental or not, within 30 days before.
- Pregnant patient or patient with breastfeeding.
- Patient under administrative supervision.
- Regular follow-up impossible for various reasons (psychological, familial, economical, and social).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Hôpital Beaujon - Service de Chirurgie
Clichy, 92118
Hôpital Henri Mondor
Créteil, 94010
Hôpital saint-Eloi
Montpellier, 34295
CHU Nancy - Hôpital Brabois
Nancy, 54000
CHU- Hotel Dieu
Nantes, 44093
CHU Poitiers
Poitiers
Centre Eugene Marquis
Rennes, 35042
About this study
Official title: An Open-label, Multicenter, Phase II Trial, to Evaluate the Efficacy of Intra-hepatic Administration of Yttrium 90-labelled Microspheres (Therasphere®, Nordion) in Association With Intravenous Chemotherapy With Gemcitabine and Cisplatin for the Treatment of Intra-hepatic Cholangiocarcinoma, First Line.
The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.
- Conditions
- Cholangiocarcinoma
- Being tested
- Therasphere® in association with Gemcitabine and Cisplatin
- Keywords
- Intra-hepatic Cholangiocarcinoma treatment
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therasphere® in association with Gemcitabine and CisplatinRadiation
Also called 90-Yttrium theraspheres
Therasphere® is a radioelement
| Study group | Role | What they receive |
|---|---|---|
| Therasphere® | Experimental | Therasphere® in association with Gemcitabine and Cisplatin Receives: Radiation: Therasphere® in association with Gemcitabine and Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological response rate to the treatment with the association of chemotherapy and radioembolization
Evaluation according RECIST 1.1 criteria. Rate will be reassessed every 8 weeks
Measured: 3 months after radioembolization
Secondary outcomes (6)
Tolerance of intra-hepatic administration of Yttrium 90-labelled microspheres in association with intravenous chemotherapy with Gemcitabine and Cisplatin assessed according NCI/CTC AE version 4.
Grade 3-4 toxicity appearance.Time between 1st treatment administration and date of 1st appearance of a grade 3-4 toxicity or date of last toxicities assessment in case no grade 3-4 toxicity
Measured: Up to 24 months
Tumor markers changes (CA19.9, CEA and AFP)
Markers will be analysed every 8 weeks during treatment period and if applicable every 12 weeks after surgery
Measured: Up to 24 months
Radiological response rate by the CHOI criteria
every 8 weeks and every 12 weeks after surgery if applicable
Measured: Up to 24 months
Change in metabolic activity measured by TEP
Measured: Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres
Changes of liver volume
Every 8 weeks during treatment and every 12 weeks after surgery if applicable
Measured: Up to 24 months
Tumoral and non-tumoral dosimetric assessment of the liver
Data obtained from SPECT/CT performed at each hepatic scintigraphy
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eveline Boucher, MD, Principal investigator, Centre Eugene Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912053
- Sponsor's protocol ID
- 2012-EB-CHOL-Th
- Other IDs
- 2012-001213-16, A121007-71
- Acronym
- MispheC
- Status last verified
- Jan 2018
- First submitted
- 17 Jul 2013
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase II Trial, to Evaluate the Efficacy of Intra-hepatic Administration of Yttrium 90-labelled Microspheres (Therasphere®, Nordion) in Association With Intravenous Chemotherapy With Gemcitabine and Cisplatin for the Treatment of Intra-hepatic Cholangiocarcinoma, First Line.
- ClinicalTrials.gov ID
- NCT01912053
- Acronym / sponsor ID
- MispheC / 2012-EB-CHOL-Th
- Conditions
- Cholangiocarcinoma
- Keywords
- Intra-hepatic Cholangiocarcinoma treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 30 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 purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therasphere® | Experimental | Radiation: Therasphere® in association with Gemcitabine and CisplatinTherasphere® in association with Gemcitabine and Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed intra-hepatic cholangiocarcinoma.
- Measurable target of at least 2 cm diameter.
- Healthy liver or cirrhosis CHILD < B8.
- WHO-PS: 0-1.
- Age ≥ 18 years.
Key exclusion criteria (20 listed)
- Pancreas cancer or duodenum cancer invading the bile duct or ampullary cancer. Cholangiocarcinoma of the bile ducts: hilar, main duct, gallbladder.
- Extra-hepatic metastasis (including local lymph nodes measuring > 30 mm).
- Primary sclerosing cholangitis.
- History of chemoembolization or radioembolization.
- Cirrhose CHILD > B7
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 |
|---|---|---|
| Therasphere® in association with Gemcitabine and CisplatinAlso: 90-Yttrium theraspheresTherasphere® is a radioelement | Radiation | Therasphere® |
Primary outcome
Radiological response rate to the treatment with the association of chemotherapy and radioembolization
Time frame: 3 months after radioembolization
Evaluation according RECIST 1.1 criteria. Rate will be reassessed every 8 weeks
6 secondary outcomes
Tolerance of intra-hepatic administration of Yttrium 90-labelled microspheres in association with intravenous chemotherapy with Gemcitabine and Cisplatin assessed according NCI/CTC AE version 4.
Time frame: Up to 24 months
Tumor markers changes (CA19.9, CEA and AFP)
Time frame: Up to 24 months
Radiological response rate by the CHOI criteria
Time frame: Up to 24 months
Change in metabolic activity measured by TEP
Time frame: Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres
Changes of liver volume
Time frame: Up to 24 months
Tumoral and non-tumoral dosimetric assessment of the liver
Time frame: Up to 6 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 11 May 2018.
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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.
Eveline Boucher, MD principal investigator
Centre Eugene Marquis
7 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 Therasphere® in association with Gemcitabine and Cisplatin in people with Cholangiocarcinoma, run by Center Eugene Marquis at 7 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 11 inclusion and 20 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
Radiological response rate to the treatment with the association of chemotherapy and radioembolization (time frame: 3 months after radioembolization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2018.