Radioembolization in Elderly/ Fragile Patients With mCRC

NCT05092880 | Recruiting Phase 2 DMC

• 1 other identifier: CAIRO7
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  4 years

Secondary Outcomes (7)

• Adverse event frequency and grade according to CTCAE version 5.0

  3.5 years

• Quality of life (EORTC quality of life questionnaire number C30)

  3.5 years

• Quality of life (EORTC quality of life questionnaire number CR29)

  3.5 years

• Quality of life (Multidimensional Fatigue Inventory: MFI-20)

  3.5 years

• Overall survival

  5 years

Study Arms (2)

Standard of care first-line systemic therapy

ACTIVE COMPARATOR

capecitabine plus anti-VEGF antibody

Drug: Standard of care first-line systemic therapy

Radioembolization

EXPERIMENTAL

radioembolization of liver with holmium-166 microspheres

Device: radioembolization

Interventions

radioembolization DEVICE

holmium-166 microspheres

Radioembolization

Standard of care first-line systemic therapy DRUG

Capecitabine plus anti-VEGF antibody

Standard of care first-line systemic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have given written informed consent.
• Female or male patients aged ≥18 years.
• Metastatic colorectal cancer, with metastases confined to the liver, previously not systemically treated.
• Previous local treatment of liver metastases by resection of a maximum of two liver segments and/or local ablation is allowed.
• Elderly/frail patients, according to the local investigator not eligible for local treatments or intensive systemic regimens with combination chemotherapy.
• ECOG Performance status 0-2 (Table 1).
• Eligible for systemic treatment with capecitabine + anti-VEGF antibody.
• 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.

You may not qualify if:

• Previous systemic treatment for metastatic disease.
• Previous adjuvant treatment completed within 6 months prior to randomization.
• Symptoms of primary tumour, if in situ, that require intervention; prior treatment with (chemo)radiotherapy and/or resection of primary tumor is allowed.
• Resection of more than 2 liver segments, 2-stage procedures and/or radiotherapy of liver metastases.
• Eligible for more intensive systemic regimens (i.e. doublet or triplet chemotherapy).
• Eligible for local treatment of liver metastases (e.g. surgical resection, ablation).
• 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.
• Non-correctable INR \>2.0.
• 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.
• Pregnancy or breastfeeding.
• Mental disorders that may compromise patient compliance.
• 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.
• Body weight over 150 kg (because of maximum table load).
• Known severe allergy for intravenous contrast fluids.
• Participation to another investigational study.

Sponsors & Collaborators

• UMC Utrecht: lead
• Dutch Colorectal Cancer Group: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nuclear Medicine

Model Details: randomized phase 2

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: October 26, 2021
• Study Start: June 1, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)