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)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 220

Inclusion Criteria

4.2 Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Patients must have given written informed consent.
2. Female or male patients aged >=18 years.
3. Metastatic colorectal cancer, with metastases confined to the liver,
previously not systemically treated.
4. Previous local treatment of liver metastases by resection of a maximum of
two liver segments and/or local ablation is allowed.
5. Elderly/frail patients, according to the local investigator not eligible for
local treatments or intensive systemic regimens with combination chemotherapy.
6. ECOG Performance status 0-2
7. Eligible for systemic treatment with capecitabine + anti-VEGF antibody.
8. Adequate bone marrow (Hb >= 6 mmol/L, WBC >= 3x109/L, platelets >= 100x109/L),
liver (serum bilirubin <= 1x upper limit of normal (ULN), Albumin >= 30 g/L,
/ALAT <= 5x (ULN), and renal (GFR >= 40 ml/min) functions.

Exclusion Criteria

4.3 Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Previous systemic treatment for metastatic disease.
2. Previous adjuvant treatment completed within 6 months prior to randomization.
3. Symptoms of primary tumor, if in situ, that require intervention; prior
treatment with (chemo)radiotherapy and/or resection of primary tumor is
allowed.
4. Resection of more than 2 liver segments, 2-stage procedures and/or
radiotherapy of liver metastases.
5. Eligible for more intensive systemic regimens (i.e. doublet or triplet
chemotherapy).
6. Eligible for local treatment of liver metastases (e.g. surgical resection,
ablation).
7. Presence of extrahepatic metastases; the presence of small (<= 1 cm) lesions
outside the liver on CT scan that are not clearly suspicious for metastases
and/or the presence of enlarged hilar lymph nodes in the liver up to a maximal
diameter of 2 cm is allowed.
8. Non-correctable INR >2.0.
9. Any serious and/or chronic liver disease preventing the safe administration
of radioembolization
10. Any serious comorbidity preventing the safe administration of anti-VEGF
antibody treatment. This includes uncontrolled hypertension or treatment with
>=3 antihypertensive drugs, arterial (cerebro)vascular event within the past 12
months, history of bleeding, history of GI perforation, or presence of
fistulae.
11. Pregnancy or breastfeeding.
12. Mental disorders that may compromise patient compliance.
13. Active second malignancy within the previous 5 years, with the exception of
adequately treated basal cell carcinoma of skin and in situ carcinoma of
cervix.
14. Body weight over 150 kg (because of maximum table load).
15. Known severe allergy for intravenous contrast fluids.
16. Actual or planned participation to another investigational study which may
compromise any endpoint of the study. This also applies to any intervention
that may influence quality of life.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>efficacy of RE in terms of PFS in CRC patients with liver-only metastases who<br /><br>are candidates for palliative systemic treatment with capecitabine plus<br /><br>anti-VEGF antibody (bevacizumab or biosimilar).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>•safety/toxicity.<br /><br>•cost-effectiveness.<br /><br>•quality of life (QoL).<br /><br>•overall survival.<br /><br>•PFS in the subgroups of patients with and without their primary tumour in situ</p><br>