Acronym
CAIRO 7
Name of the study
Radioembolization with 166Ho-microspheres in elderly and/or fragile patients with previously untreated unresectable liver-only metastases of colorectal cancer, CAIRO7 study endorsed by the Dutch Colorectal Cancer Group (DCCG)
Researchers and contact information
PI: Prof. dr. Cornelis J.A. Punt, medical oncologist
Email: C.J.A.Punt@umcutrecht.nl
Coordinating investigator: Prof. dr. Marnix. G.E.H. Lam, nuclear medicine physician
Email: M.Lam@umcutrecht.nl
Independent expert: Drs. R.S van Leeuwaarde
Email: R.vanLeeuwaarde@umcutrecht.nl
Tel.: +31 88 755 6 3 08
Studyteam: CAIRO7@umcutrecht.nl
Summary study
In The Netherlands, ±14.000 people/year are diagnosed with colorectal cancer (CRC), and 50% of patients already have/will develop distant metastases, most commonly to the liver. Standard treatment is palliative systemic treatment, which prolongs overall survival (OS). In only a small subset of patients with liver-only metastases, local treatment (i.e. surgery) of metastases is possible with curative intent, either initially or after downsizing by intensive systemic treatment. The average age at CRC diagnosis is 69 yrs, and 30% of CRC patients are ≥75 yrs. Thus, many patients are too old and/or fragile to allow intensive systemic regimens or major surgery. In frail/elderly patients the standard treatment is capecitabine plus an antibody against the vascular endothelial growth factor (VEGF, i.e. bevacizumab or biosimilar), given until disease progression or unacceptable toxicity, resulting in a median progression free survival (PFS) of 8.5-9.2 months. Capecitabine-induced hand-foot syndrome and diarrhoea are the most commonly occurring toxicities. Prolonged exposure to CTCAE grade 2 toxicity in frail or elderly patients may already significantly impact quality of life and daily functioning. Therefore, treatments with less toxicity would be of great value for these patients.
Radioembolization (RE) is a minimally invasive treatment with administration of radioactive microspheres into the hepatic artery via a microcatheter. Since tumors are preferentially supplied by the hepatic artery, most microspheres get trapped in the tumor. RE has been shown a feasible and safe procedure for the late-line treatment of unresectable CRC liver metastases. These data compare favourably with the toxicity data of capecitabine plus bevacizumab, but this should be validated in a prospective study in first-line.
The proposed study investigates the efficacy of RE as an alternative, better tolerated and more cost-effective treatment option in elderly or frail patients compared to chronic systemic treatment with comparable progression-free survival.
Intervention
Individualized holmium-166 radioembolization (166Ho-RE) will be performed via a catheter during angiography. Dosimetry-based treatment planning will be individualized using Q-Suite™ software. The comparator, standard systemic treatment, will be given by the local investigator and will consist of capecitabine orally 1000 mg/m2 bid day 1-14 + anti-VEGF antibody i.v. 7.5 mg/kg day 1 at 3-weekly cycles, continued until disease progression or unacceptable toxicity.
Participating centers. Dit zijn de centra tot nu toe maar kan uitbreiden
Albert Schweitzer ziekenhuis
Alrijne ziekenhuis Leiderdorp
Amphia ziekenhuis Breda
Antonius zorggroep Sneek
AmsterdamUMC
NKI/AvL
Bravis ziekenhuis Roosendaal
EMC
Franciscus Gasthuis en Vlietland
Gelre ziekenhuizen Apeldoorn
IKAZIA ziekenhuis Rotterdam
Isala Zwolle
Jeroen Bosch ziekenhuis
Laurentius ziekenhuis Roermond
LUMC
Maxima Medisch Centrum Veldhoven
Meander Medisch Centrum Amersfoort
Medisch Centrum Leeuwarden
Maastricht UMC
Nij Smellinghe Ziekenhuis Drachten
Noordwest Ziekenhuisgroep Alkmaar
Radboud UMC Nijmegen
Reinier de Graaf, Delft
Rivas Zorggroep Gorinchem
Rode Kruis ziekenhuis Beverwijk
Spaarne Gasthuis Hoofddorp
St. Antonius Ziekenhuis Nieuwegein
Stichting BovenIJ Ziekenhuis Amsterdam
Tergooi Hilversum
UMCG
UMCU
VieCuri MC Venlo
Wilhelmina ziekenhuis Assen
Zaans MC Zaandam
ZorgSaam Zeeuws Vlaanderen