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

NCT ID: NCT03175146

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2021-01-31

Brief 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

Detailed Description

SBRT for Oligo-metastatic Colorectal cancer

Conditions

Colonic Neoplasms; Neoplasm Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Stereotactic Body Radiation Therapy

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

5 treatments given over 2 weeks

Interventions

Stereotactic Body Radiation Therapy

5 treatments given over 2 weeks

Intervention Type: RADIATION

Other Intervention Names

SBRT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richie Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

Tom Baker Cancer Centre

Central Contacts

Richie Sinha, MD

Role: CONTACT

richie.sinha@ahs.ca

403-476-2601

Other Identifiers

CRC L-SBRT 15-01

Identifier Type: -

Identifier Source: org_study_id