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

NCT03175146 | Unknown DMC

• 1 other identifier: CRC L-SBRT 15-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Colonic Neoplasms; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• Response rate within the treated liver lesion

  RECIST Response

  6 months

Secondary Outcomes (5)

• Progression-free survival

  Up to 5 years

• Toxicity

  From date of randomization up to 5 years

• Quality of Life

  From date of Randomization to Death or Progression or 5 years whichever comes first.

• Median survival

  From date of randomization upto 5 years

• Overall survival

  From date of randomization upto 5 years

Study Arms (1)

Experimental

EXPERIMENTAL

Stereotactic Body Radiation Therapy

Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

5 treatments given over 2 weeks

Also known as: SBRT

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed Colo-rectal Cancer
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

MeSH Terms

Conditions

Colonic Neoplasms; Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Richie Sinha, MD

  Tom Baker Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richie Sinha, MD

CONTACT

403-476-2601; richie.sinha@ahs.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: June 5, 2017
• Study Start: September 1, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: June 7, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share