Radioembolization in Elderly/ Fragile Patients With mCRC

• Status: Not yet recruiting
• Trial end date: 2028-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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 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.

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborator: Dutch Colorectal Cancer Group

Criteria

Inclusion 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 (Table 1).

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), ASAT/ALAT ≤ 5x ULN), and renal (GFR ≥ 40 ml/min) functions.

Exclusion Criteria:

1. Previous systemic treatment for metastatic disease.

2. Previous adjuvant treatment completed within 6 months prior to randomization.

3. Symptoms of primary tumour, 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 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.

10. Pregnancy or breastfeeding.

11. Mental disorders that may compromise patient compliance.

12. 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.

13. Body weight over 150 kg (because of maximum table load).

14. Known severe allergy for intravenous contrast fluids.

15. Participation to another investigational study.