NCT01347333

Brief Summary

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

March 3, 2020

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

8 years

First QC Date

May 2, 2011

Results QC Date

January 22, 2019

Last Update Submit

February 19, 2020

Conditions

Liver MetastasesHepatocellular CarcinomaIntrahepatic Cholangiocarcinoma

Keywords

liver metastasesstereotactic radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Local Tumor Recurrence Rate

    Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.

    5 years

Secondary Outcomes (1)

  • Late Complication Rates

    5 years

Study Arms (2)

liver metastases

OTHER

Oligometastases (1-3) with aggregate tumor diameter \< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes

Radiation: Stereotactic body radiosurgery

Primary Liver Tumors

OTHER

Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma

Radiation: Stereotactic Body Radiotherapy

Interventions

Stereotactic body radiosurgeryRADIATION

36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)

liver metastases
Stereotactic Body RadiotherapyRADIATION

26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)

Primary Liver Tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient age \>= 18 years
  • Zubrod performance status of 0-3
  • Oligometastases (1-3) with aggregate tumor diameter \< 6 cm
  • Metastases from neuroendocrine tumors with functional endocrine syndromes for symptom palliation
  • Unresectable hepatocellular carcinoma (HCC)
  • Unresectable intrahepatic cholangiocarcinoma (IHCC)
  • Maximum tumor diameter \< 6 cm
  • Adequate liver function:
  • Total bilirubin \< 3 mg/dL Serum albumin \> 2.5 g/dL Serum levels of liver enzymes \< 3 times the upper limit of normal Normal PT and PTT unless patient is receiving anticoagulant medication
  • \- Signed study-specific consent form

You may not qualify if:

  • Maximum tumor diameter \> 6 cm
  • Prior radiotherapy to the liver
  • Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
  • Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularCholangiocarcinoma

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
Michelle McFarland, MPH, CHRC
Organization
Mercy Research
michelle.mcfarland@mercy.net
314-251-8827

Study Officials

  • Bethany G Sleckman, MD

    Mercy Hospital St. Louis

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 4, 2011

Study Start

September 1, 2008

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 3, 2020

Results First Posted

March 3, 2020

Record last verified: 2020-02

Locations

US(1)