A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely

Neoplasm Metastasis Clinical Trial

Official title:

Stereotactic Body RadioTherapy (SBRT) for Oligo-metastatic Colo-rectal Cancer With Bio-marker Evaluation for Early Progression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03175146
• Other study ID #: CRC L-SBRT 15-01
• Status: Not yet recruiting
• Phase: N/A
• First received: January 6, 2016
• Last updated: June 5, 2017
• Start date: September 2017
• Est. completion date: January 2021

Study information

• Verified date: May 2017
• Source: AHS Cancer Control Alberta
• Contact: Richie Sinha, MD
• Phone: 403-476-2601
• Email: richie.sinha[@]ahs.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study will evaluate if "curative intent" SBRT can provide high response rates and clinically meaningful cancer control with acceptable toxicity specifically in patient with metastatic colorectal cancer (mCRC) who do not have surgical options and are no longer responding to systemic therapy

Description:

SBRT for Oligo-metastatic Colorectal cancer

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Pathologically confirmed Colo-rectal Cancer

• 1-3 Liver metastasis measurable on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)

• Surgically resected primary disease

• Technically/medically inoperable or patient declined surgery

• Progression or Stability after at least 1 Line of chemotherapy

• Adequate marrow function: Hb > 80g/L, Platelets > 100 x 109/L, White blood cell > 2 x 109/L

• Eastern Cooperative Oncology Group (ECOG) status 0-2

• Age > 18 years

• Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

• Prior liver radiation, or radiation in close proximity to planned treatment sites

• Prior invasive malignancy

• Severe, active co-morbidity

• Active hepatitis or Child Pugh Score B (9) or worse

• Pregnant or nursing women

• Extra hepatic disease: Any Bone/Any Brain, 2 or more Lung metastasis

• Life expectancy < 6 mo from any cause

• Concurrent chemotherapy

• Response to prior chemotherapy with minimal measurable disease in liver

Related Conditions & MeSH terms

• Colonic Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiation Therapy
5 treatments given over 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate within the treated liver lesion	RECIST Response	6 months
Secondary	Progression-free survival	Any progression of the disease	Up to 5 years
Secondary	Toxicity	Grade 3 CTCAE events	From date of randomization up to 5 years
Secondary	Quality of Life	Fact - H quality of life instrument	From date of Randomization to Death or Progression or 5 years whichever comes first.
Secondary	Median survival	Median survival	From date of randomization upto 5 years
Secondary	Overall survival	Survival	From date of randomization upto 5 years