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Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver

Primary Purpose

Colorectal Carcinoma, Liver Metastases

Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
MWA
SBRT
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of

    1. non-resectability
    2. small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection
    3. previous extensive liver surgery
    4. comorbidity
  2. The multidisciplinary team should all agree that both percutaneous or open surgical MW-ablation and SBRT are safe as first treatment choice for the individual patient.
  3. Tumor sizes ≤4.0 cm
  4. Age > 18 years
  5. Signed informed consent

Exclusion Criteria:

  1. Previous radiotherapy to the liver
  2. Liver volume < 700 ml
  3. Another active cancer disease within the past 36 months
  4. Not able to understand written or oral protocol information

Sites / Locations

  • RighospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MWA

SBRT

Arm Description

Percutaneous ultrasound-guided MWA or open surgery MWA. The patient is fully anesthetized during the treatment.

3 fractions of 15 Gy (in total 45 Gy), 3 fractions per week. The dose is prescribed to the PTV encompassing 67% isodose. The SBRT plan is normalized such that the mean dose to the GTV is 100% = 67.5 Gy.

Outcomes

Primary Outcome Measures

Freedom from local lesion progression (analyzed on patient-level)
Defined as the time from randomization to local progression Censoring: death from any cause, last follow-up No censoring on disease progression outside of the treated lesions Local lesion progression is defined as >20% increase in the longest diameter and minimum 5 mm increase talking as reference the smallest longest diameter recorded since the treatment started in any of the treated lesions

Secondary Outcome Measures

Overall survival
Defined as the time from randomization to death from any cause Censoring: last follow-up
Freedom from local lesion progression (analyzed on lesion-level)
Defined as the time from randomization to local progression Censoring: death from any cause, last follow-up No censoring on disease progression outside of the treated lesions Local lesion progression is defined as >20% increase in the longest diameter and minimum 5 mm increase talking as reference the smallest longest diameter recorded since the treatment started in any of the treated lesions
≥ grade 3 toxicity potentially associated with the treatment
Defined as the time from randomization to first ≥ grade 3 toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Censoring: death from any cause, last follow-up
Toxicity profile as descriptive statistics
Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Quality of life as descriptive statistics: EORTC QLQ-C30
Using EORTC QLQ-C30

Full Information

First Posted
August 27, 2018
Last Updated
January 21, 2022
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03654131
Brief Title
Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver
Official Title
Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver - a Randomized Phase II Trail
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
July 25, 2023 (Anticipated)
Study Completion Date
July 25, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a randomized phase II trial between microwave ablation (MWA) and stereotactic body radiotherapy (SBRT) - two standard treatment modalities for colorectal patients with metastatic disease in the liver. Primary endpoint is freedom form local lesion progression.
Detailed Description
Colorectal cancer patients with 1-3 liver metastases (diameter ≤4.0 cm) found unsuitable for resection are randomized 1:1 to either MWA or SBRT. Chemotherapy is allowed. Curative treatment of extrahepatic disease must be initiated in patients with lung metastases and/or primary tumors. Patients will be analyzed according to the intention-to-treat principle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma, Liver Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MWA
Arm Type
Active Comparator
Arm Description
Percutaneous ultrasound-guided MWA or open surgery MWA. The patient is fully anesthetized during the treatment.
Arm Title
SBRT
Arm Type
Active Comparator
Arm Description
3 fractions of 15 Gy (in total 45 Gy), 3 fractions per week. The dose is prescribed to the PTV encompassing 67% isodose. The SBRT plan is normalized such that the mean dose to the GTV is 100% = 67.5 Gy.
Intervention Type
Device
Intervention Name(s)
MWA
Intervention Description
Patients are allocated to one of the two arms in a 1:1 randomization
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
Patients are allocated to one of the two arms in a 1:1 randomization
Primary Outcome Measure Information:
Title
Freedom from local lesion progression (analyzed on patient-level)
Description
Defined as the time from randomization to local progression Censoring: death from any cause, last follow-up No censoring on disease progression outside of the treated lesions Local lesion progression is defined as >20% increase in the longest diameter and minimum 5 mm increase talking as reference the smallest longest diameter recorded since the treatment started in any of the treated lesions
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Defined as the time from randomization to death from any cause Censoring: last follow-up
Time Frame
3 years
Title
Freedom from local lesion progression (analyzed on lesion-level)
Description
Defined as the time from randomization to local progression Censoring: death from any cause, last follow-up No censoring on disease progression outside of the treated lesions Local lesion progression is defined as >20% increase in the longest diameter and minimum 5 mm increase talking as reference the smallest longest diameter recorded since the treatment started in any of the treated lesions
Time Frame
3 years
Title
≥ grade 3 toxicity potentially associated with the treatment
Description
Defined as the time from randomization to first ≥ grade 3 toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Censoring: death from any cause, last follow-up
Time Frame
3 years
Title
Toxicity profile as descriptive statistics
Description
Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
3 years
Title
Quality of life as descriptive statistics: EORTC QLQ-C30
Description
Using EORTC QLQ-C30
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of non-resectability small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection previous extensive liver surgery comorbidity The multidisciplinary team should all agree that both percutaneous or open surgical MW-ablation and SBRT are safe as first treatment choice for the individual patient. Tumor sizes ≤4.0 cm Age > 18 years Signed informed consent Exclusion Criteria: Previous radiotherapy to the liver Liver volume < 700 ml Another active cancer disease within the past 36 months Not able to understand written or oral protocol information
Facility Information:
Facility Name
Righospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Signe Normann Risum, MD, PhD
Phone
+45 35453545
Email
rigshospital.rigshospitalet@regionh.dk
First Name & Middle Initial & Last Name & Degree
Signe Normann Risum, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver

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