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Clinical Trial NCT05775146 for Colorectal Cancer, Liver Metastasis Colon Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases Phase 2 24
Clinical Trial NCT05775146 is designed to study Treatment for Colorectal Cancer, Liver Metastasis Colon Cancer. It is a Phase 2 interventional study that is recruiting, having started on 18 June 2024, with plans to enroll 24 participants. Led by AHS Cancer Control Alberta, it is expected to complete by 30 June 2028. The latest data from ClinicalTrials.gov was last updated on 27 June 2025.
Brief Summary
The purpose of this study is to prospectively evaluate the feasibility of SBRT for the management of synchronous oligo metastatic liver metastases from colorectal cancers.
Detailed Description
This will be a phase II feasibility trial to evaluate ablative radiation for the management of colorectal cancer with potentially resectable/ablatabale synchronous oligo-metastases.
In this study, following completion of the neo-adjuvant component of treatment, patients will be re-staged (as is the current standard of care) and can then proceed for SBRT to the liver lesion. Patients who may have responded very well ...
Show MoreOfficial Title
Phase II Single Arm Feasibility Trial to Evaluate Stereotactic Ablative Radiation of Metastases for the Management of Colorectal Cancer With Synchronous Oligo-metastases in Liver
Conditions
Colorectal CancerLiver Metastasis Colon CancerOther Study IDs
- IIT-0023
NCT ID Number
Start Date (Actual)
2024-06-18
Last Update Posted
2025-06-27
Completion Date (Estimated)
2028-06-30
Enrollment (Estimated)
24
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSBRT to the metastatic liver +/- lung lesions All rectal cancer patients included in the trial will receive short course radiation to the pelvis (with 25 Gy in 5 fractions) followed by chemotherapy with either 6 cycles of 3 weekly CAPOX chemotherapy or 9 cycles of 2 weekly FOLFOX. All colon cancer patients will receive 6 cycles of 3 weekly CAPOX or 9 cycles of 2 weekly FOLFOX. Patients will proceed for SBRT to the metastatic liver +/\_ lung lesions and resection...Show More | stereotactic body radiation treatment (SBRT) SBRT uses 3D imaging to target high doses of radiation to the affected area. There is very little damage to the surrounding healthy tissue. SBRT works by damaging the DNA of the targeted cells. Then, the affected cells can't reproduce, which causes tumors to shrink. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Progression free survival (PFS) | Defined as Time from diagnosis to disease progression at any site or death | From date of diagnosis upto 24 months in follow up |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Quality of Life (QOL)C309v3 | To study the Quality of Life as measured by QLQ (quality of life questionnaire)-C309v3) | Baseline QOL will be assessed upto 24 months follow up |
Quality of Life (QOL)EORTC | To study the Quality of Life as measured by QLQ (quality of life questionnaire)- EORTC CR29 Questionnaire | Baseline QOL will be assessed upto 24 months follow up |
Cancer Specific Survival (CSS) | Defined as the time from diagnosis to death due to the cancer | Upto 24 months |
Overall Suvival(OS) | Defined as the time from diagnosis to death due to any cause . | Expected to be within 3 months post treatment |
Toxicity Assessment | Treatment related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5 | Toxicity assessment will be done upto 24 months in follow up |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Age ≥ 18 years
- ECOG (Eastern Cooperative Oncology Group) 0-2
- Able to provide written informed consent
- 1-5 Liver lesions with max size of ≤5cm for a single lesion and restricted to one lobe of liver; deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent
- Liver lesion identified within 3 months of diagnosis of primary and deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent
- Plan for resection of primary with curative intent
- Patients with liver metastases and potentially resectable/ablatable lung mets can be included.
- Colon cancer patients who have undergone upfront resection of primary colonic lesion can be included
- Able and willing to comply with the terms of the protocol including health-related quality of life (HRQoL) questionnaires
- Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause.
- Females must not be breastfeeding
- Male patients should agree to not donate sperm during the study
- Extra-hepatic metastases (except potentially resectable lung mets)
- Not a suitable candidate for liver resection surgery
- Not a suitable candidate for SBRT
- Past history of cancer within 5 years (except basal cell carcinoma)
- Patients who have undergone previous surgery or ablation for liver lesions
- Planned simultaneous resection of primary and liver metastases
- Pregnancy
- Patients with Child-Pugh C and documented cirrhosis
AHS Cancer Control AlbertaStudy Central Contact
Contact: Aswin Abraham, 780-432-8516, [email protected]
1 Study Locations in 1 Countries
Alberta
Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada
Aswin Abraham, Contact, 7804328516, [email protected]
Recruiting