Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04081168
Other study ID # NL68326.029.19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2020
Est. completion date January 15, 2025

Study information

Verified date December 2022
Source Amsterdam UMC, location VUmc
Contact S. van der Lei, MD
Phone +31204443047
Email s.vanderlei@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multiple articles report that thermal ablation is a safe and effective treatment for unresectable colorectal liver metastases (CRLM) ≤3cm. However efficacy of thermal ablation decreases with increasing lesion size. Guidelines state that thermal ablation is the preferred option for unresectable CRLM ≤3cm and stereotactic body radiotherapy (SBRT) when thermal ablation is not possible. It remains uncertain what local treatment method should be recommended for unresectable CRLM of 3-5cm.


Description:

Objective: The primary objective of this study is to compare efficacy of MWA to the efficacy of SBRT with regards to the primary endpoint (local tumour progression free survival at 1 year [1-year LTPFS]) in patients with unresectable CRLM (3 - 5 cm) that are unsuitable for surgery due to either comorbidities, a history of extensive abdominal surgery, a poor performance status or due to a certain unfavourable anatomical location of the tumour. Study design: COLLISION XL is a prospective multi-centre phase-II randomized controlled trial. Study population: 68 patients with 1-3 unresectable lesions of 3 - 5cm, unsuitable for (further) chemotherapy regimens, suitable for both MWA and SBRT and no or limited extrahepatic disease (1 extrahepatic lesion is allowed, not including positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis) are considered eligible. Supplementary resections for resectable lesions and thermal ablations for unresectable CRLM ≤3cm are allowed. A maximum number of 10 CRLM are allowed for patients with no extrahepatic disease and a maximum number of 5 lesions are allowed for patients with limited extrahepatic disease. Intervention: SBRT or MWA. The panel, consisting of at least two interventional radiologists, two hepatobiliary surgeons and two radiation oncologists, will appoint lesions of 3-5cm that are unresectable and suitable for both MWA and SBRT, as target lesions. All lesions that are not suitable for ablation should be resectable and all unresectable lesions <3cm should be suitable for thermal ablation. Main study parameters/endpoints: Primary endpoint is local tumour progression free survival (LTPFS) at 1 year from randomization. Secondary endpoints are local tumour progression free survival time, OS, disease-free survival (DFS), time to progression (TTP), procedural morbidity/toxicity and mortality, assessment of pain and quality of life (QoL) and cost-effectiveness ratio (ICER).


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date January 15, 2025
Est. primary completion date September 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1-3 unresectable CRLM size 3-5 cm eligible for both MWA and SBRT (target lesions); - Additional CRLM are allowed if considered either resectable or ablatable and <3cm - No or limited extrahepatic disease (1 extrahepatic lesion is allowed, not including positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis); - For subjects with liver only disease the maximum number of CRLM is 10; for subjects with limited extrahepatic disease the maximum number of CRLM is 5; - Prior focal liver treatment is allowed - Subjects without prior focal liver treatment should be either unsuitable for 1st line chemotherapy or have progressed under/after 1st-line chemotherapy; - Subjects with recurrent (either local or distant-hepatic) CRLM after previous focal treatment should be unsuitable for (further) systemic therapy (further downsizing or conversion to resectable disease improbable). Exclusion Criteria: - Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites); - Pregnant or breast-feeding subjects; - Immunotherapy = 6 weeks prior to the procedure; - Chemotherapy = 6 weeks prior to the procedure; - Severe allergy to contrast media not controlled with premedication.

Study Design


Intervention

Device:
Stereotactic Body Radiotherapy
Patients will undergo Stereotactic Body Radiotherapy (SBRT)
Microwave Ablation
Patients will undergo Microwave Ablation (MWA)

Locations

Country Name City State
Netherlands Amsterdam UMC Amsterdam Noord Holland

Sponsors (1)

Lead Sponsor Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary One-year local tumor progression-free survival One-year local tumor progression-free survival 1 year
Secondary Timo-to-local tumor progression Timo-to-local tumor progression 5 years
Secondary Overall survival (OS) Overall survival (OS) 5 years
Secondary Disease-Free Survival (DFS) Disease-Free Survival (DFS) 5 years
Secondary Mortality Mortality 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT03941080 - Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
Completed NCT03213314 - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies N/A
Completed NCT03647839 - Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer Phase 2
Recruiting NCT05057052 - Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis Phase 2
Terminated NCT02316496 - Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study Phase 2
Completed NCT03251612 - Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT02380443 - AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer Phase 2
Recruiting NCT02149784 - Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients Phase 3
Recruiting NCT01959061 - Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases Phase 4
Terminated NCT01668680 - Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma Phase 2
Recruiting NCT05068531 - Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients
Not yet recruiting NCT04525807 - Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
Completed NCT04482608 - The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival
Recruiting NCT03193710 - The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved N/A
Recruiting NCT04854213 - PRELUDE-1 (Prospective Evaluation of Radiotherapy-induced Biologic Effects in Colorectal Cancer Oligometastatic Patients With LUng-limited Disease: Evolution of Cancer Genetics and Regulatory Immune Cells) N/A
Suspended NCT04108481 - Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer Phase 1/Phase 2
Completed NCT03144804 - A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer Phase 2
Completed NCT03142516 - FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status Phase 2
Active, not recruiting NCT01910610 - Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer Phase 3
Recruiting NCT05759728 - A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer Phase 1/Phase 2