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

Overview

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.

Interventions

• Radiation 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

• Progression free survival (PFS) [Time frame: From date of diagnosis upto 24 months in follow up]

Secondary outcome measures (5)

• Quality of Life (QOL)C309v3 [Time frame: Baseline QOL will be assessed upto 24 months follow up]
• Quality of Life (QOL)EORTC [Time frame: Baseline QOL will be assessed upto 24 months follow up]
• Cancer Specific Survival (CSS) [Time frame: Upto 24 months]
• Overall Suvival(OS) [Time frame: Expected to be within 3 months post treatment]
• Toxicity Assessment [Time frame: Toxicity assessment will be done upto 24 months in follow up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Cross Cancer Institute — Edmonton

Identifiers

NCT: NCT05775146 · IIT-0023

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗