Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

— MispheC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912053
• Other study ID #: 2012-EB-CHOL-Th
• Secondary ID: 2012-001213-16A1
• Status: Completed
• Phase: Phase 2
• Start date: September 2013
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: Center Eugene Marquis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically confirmed intra-hepatic cholangiocarcinoma.

2. Measurable target of at least 2 cm diameter.

3. Healthy liver or cirrhosis CHILD < B8.

4. WHO-PS: 0-1.

5. Age = 18 years.

6. Non-Metastatic disease in extra-hepatic (are permitted: local lymph nodes < 3 cm, less than 5 lung nodes < 11 mm).

7. 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.

8. Pregnancy test: negative for women of childbearing potential.

9. 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

10. Signed informed consent form.

11. Patient with national health insurance.

Exclusion Criteria:

1. Pancreas cancer or duodenum cancer invading the bile duct or ampullary cancer. Cholangiocarcinoma of the bile ducts: hilar, main duct, gallbladder.

2. Extra-hepatic metastasis (including local lymph nodes measuring > 30 mm).

3. Primary sclerosing cholangitis.

4. History of chemoembolization or radioembolization.

5. Cirrhose CHILD > B7

6. Portal vein trunk tumoral thrombosis

7. History of hepato-biliary neo adjuvant or palliative chemotherapy and/or radiotherapy.

8. Contra indication of Gemcitabine and/or Cisplatin.

9. 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.

10. Technical failure of the diagnostic arteriography.

11. Extra hepatic uptake on the pre-therapeutic scintigraphy not manageable with an arteriography.

12. Dosimetry study predicting lung exposure > 30 Gy.

13. Any unstable medical history (diabetes, hypertension …).

14. History of organ transplant.

15. Symptomatic grade 1 angina pectoris or grade = 2 angina pectoris.

16. An evolutive neuropathy.

17. Patient who already has been involved in a clinical trial with drug intake, whether this drug was experimental or not, within 30 days before.

18. Pregnant patient or patient with breastfeeding.

19. Patient under administrative supervision.

20. Regular follow-up impossible for various reasons (psychological, familial, economical, and social).

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Radiation:
• Therasphere® in association with Gemcitabine and Cisplatin
Therasphere® is a radioelement

Locations

Country	Name	City	State
France	Hôpital Beaujon - Service de Chirurgie	Clichy
France	Hôpital Henri Mondor	Créteil
France	Hôpital saint-Eloi	Montpellier
France	CHU Nancy - Hôpital Brabois	Nancy
France	CHU- Hotel Dieu	Nantes
France	CHU Poitiers	Poitiers
France	Centre Eugene Marquis	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months after radioembolization
Secondary	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	Up to 24 months
Secondary	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	Up to 24 months
Secondary	Radiological response rate by the CHOI criteria	every 8 weeks and every 12 weeks after surgery if applicable	Up to 24 months
Secondary	Change in metabolic activity measured by TEP		Change from baseline in metabolic activity 15 and 24 weeks after last treatment by microspheres
Secondary	Changes of liver volume	Every 8 weeks during treatment and every 12 weeks after surgery if applicable	Up to 24 months
Secondary	Tumoral and non-tumoral dosimetric assessment of the liver	Data obtained from SPECT/CT performed at each hepatic scintigraphy	Up to 6 months