SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

stereotactic body radiation treatment (SBRT)

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

Cross Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT to the metastatic liver +/- lung lesions

Arm Description

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 of the colorectal primary. Treatment planning is to be done using CT simulation or conventional simulation (Fluorocscopy) as per institutional practice. Simple beam arrangements, such as parallel opposed beams, are favored wherever possible.

Outcomes

Primary Outcome Measures

Progression free survival (PFS)

Defined as Time from diagnosis to disease progression at any site or death

Secondary Outcome Measures

Quality of Life (QOL)C309v3

To study the Quality of Life as measured by QLQ (quality of life questionnaire)-C309v3)

Quality of Life (QOL)EORTC

To study the Quality of Life as measured by QLQ (quality of life questionnaire)- EORTC CR29 Questionnaire

Cancer Specific Survival (CSS)

Defined as the time from diagnosis to death due to the cancer

Overall Suvival(OS)

Defined as the time from diagnosis to death due to any cause .

Toxicity Assessment

Treatment related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5

Full Information

NCT ID

NCT05775146

First Posted

February 16, 2023

Last Updated

July 14, 2023

Sponsor

AHS Cancer Control Alberta

1. Study Identification

Unique Protocol Identification Number

NCT05775146

Brief Title

SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 30, 2023 (Anticipated)

Primary Completion Date

June 30, 2028 (Anticipated)

Study Completion Date

June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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 to the systemic treatment with no-residual disease on re-staging imaging, will use pre-treatment imaging for target delineation. The advantage of SBRT is in the minimally invasive approach to treatment that may be associated with lower morbidity, better quality of life and post treatment morbidity, as well as being significantly less expensive. The planned course of the neo-adjuvant component of treatment for this study will reflect the NCCN (National Comprehensive Cancer Network) guidelines and will treat rectal cancer patients with a short course of radiation followed by 6-9 cycles of a combination chemotherapy regimen. For the colon cancer group of patients, all patients will receive 6-9 cycles (2-3 months) of neo-adjuvant systemic chemotherapy as per current standard of care. Patients with non-progressive disease at that point, will have SBRT for the metastatic lesion followed by surgery for the primary rectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Liver Metastasis Colon Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SBRT to the metastatic liver +/- lung lesions

Arm Type

Experimental

Arm Description

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 of the colorectal primary. Treatment planning is to be done using CT simulation or conventional simulation (Fluorocscopy) as per institutional practice. Simple beam arrangements, such as parallel opposed beams, are favored wherever possible.

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiation treatment (SBRT)

Intervention Description

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 Measure Information:

Title

Progression free survival (PFS)

Description

Defined as Time from diagnosis to disease progression at any site or death

Time Frame

From date of diagnosis upto 24 months in follow up

Secondary Outcome Measure Information:

Title

Quality of Life (QOL)C309v3

Description

To study the Quality of Life as measured by QLQ (quality of life questionnaire)-C309v3)

Time Frame

Baseline QOL will be assessed upto 24 months follow up

Title

Quality of Life (QOL)EORTC

Description

To study the Quality of Life as measured by QLQ (quality of life questionnaire)- EORTC CR29 Questionnaire

Time Frame

Baseline QOL will be assessed upto 24 months follow up

Title

Cancer Specific Survival (CSS)

Description

Defined as the time from diagnosis to death due to the cancer

Time Frame

Upto 24 months

Title

Overall Suvival(OS)

Description

Defined as the time from diagnosis to death due to any cause .

Time Frame

Expected to be within 3 months post treatment

Title

Toxicity Assessment

Description

Treatment related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5

Time Frame

Toxicity assessment will be done upto 24 months in follow up

Other Pre-specified Outcome Measures:

Title

Exploratory endpoints/outcomes. To identify blood biomarkers that can correlate with disease events

Description

Blood samples will be compared between the baseline and subsequent samples for changes in the expression levels of specific markers that may be associated with metastases and treatment response. These include circulating cell free DNA and exosomes. Carcino Embryonic Antigen (CEA) levels in blood will also be analysed. Micro Satellite Instability (MSI) pattern in the tumor tissue will be evaluated in the pathological tissue

Time Frame

Blood samples will be collected at baseline upto 24 months in follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aswin Abraham

Phone

780-432-8516

Email

aswin.abraham@albertahealthservices.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aswin Abraham

Organizational Affiliation

Cross Cancer Institute, Alberta Health Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aswin Abraham

Phone

7804328516

Email

aswin.abraham@albertahealthservices.ca

12. IPD Sharing Statement

Plan to Share IPD

No

Colorectal Cancer, Liver Metastasis Colon Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial