NCT00923897

Brief Summary

Palliative radiotherapy is radiation treatment given to help reduce pain or discomfort, or other symptoms related to cancer. This is used commonly for cancer that has spread to the bones and brain, and for many other primary cancers that are too advanced to be cured, including lung cancer, pancreatic cancer and head and neck cancer. The benefits of palliative radiotherapy for advanced liver cancer have not been well studied. This study is designed to help to see whether palliative radiation therapy is effective in controlling pain, discomfort or other symptoms related to liver cancer, and how this therapy Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases might affect the quality of life of patients receiving such therapy. This information will help the doctors understand if there are specific conditions under which radiation therapy is more effective and worthwhile, and how it may affect the quality of life for patients who have locally advanced hepatocellular carcinoma and hepatic metastasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_2 hepatocellular-carcinoma

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

February 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2018

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

11.7 years

First QC Date

June 16, 2009

Last Update Submit

June 14, 2019

Conditions

Hepatocellular CarcinomaHepatic Metastasis

Keywords

Hepatocellular CarcinomaHepatic MetastasisPalliative Radiation TherapyLocally advanced HCC and Hepatic Metastasis

Outcome Measures

Primary Outcomes (1)

  • To determine the change in index symptom(s) using an 11 point numerical rating scale for patients with locally advanced hepatocellular cancer or hepatic metastases treated with 8Gy

    5 years

Secondary Outcomes (4)

  • Determine the change in EORTC QLQ-C30 & FACT-Hep for patients with locally advanced HCC/hepatic metastases treated w/h 8Gy and assess the toxicity of treatment using CTC AE v3.0 toxicity score

    5 years

  • To measure changes in serum cytokines and proteomics following radiotherapy.

    5 years

  • To determine the feasibility of Cone Beam CT for simulation and treatment and optimize image quality offline.

    5 years

  • To determine serum marker and radiographic response with 8Gy

    5 years

Study Arms (1)

RT for Liver Mets and HCC

EXPERIMENTAL
Radiation: Palliative RT

Interventions

Palliative RTRADIATION

Prior to receiving radiation treatment, it is recommended that you take medications to reduce the chance of nausea related to therapy. The treatment will take approximately 30 minutes.

RT for Liver Mets and HCC

Eligibility Criteria

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

You may qualify if:

  • Patients with hepatocellular carcinoma or hepatic metastases from a solid malignancy, unsuitable for radical therapy (including resection, transplant, conformal high dose radiotherapy), confirmed by biopsy or imaging
  • Symptoms of hepatic pain, discomfort, nausea, or fatigue requiring palliation
  • KPS\>60
  • Expected survival of greater than 3 months
  • Platelet count \> 25 bil/L, Hemoglobin \> 70 g/L, INR\<3, Bilirubin\<100 umol/L, AST \< 350 U/L or ALT\< 400 U/L
  • Have signed an informed consent form approved by the Research Ethics Board (REB) at Princess Margaret Hospital

You may not qualify if:

  • Chemotherapy or novel drug within the past 2 weeks
  • TACE(transarterial chemoembolization)within the past 1 month
  • Plan for active treatment of the hepatocellular carcinoma or hepatic metastases, including TACE or RFA or ETOH injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Soliman H, Ringash J, Jiang H, Singh K, Kim J, Dinniwell R, Brade A, Wong R, Brierley J, Cummings B, Zimmermann C, Dawson LA. Phase II trial of palliative radiotherapy for hepatocellular carcinoma and liver metastases. J Clin Oncol. 2013 Nov 1;31(31):3980-6. doi: 10.1200/JCO.2013.49.9202. Epub 2013 Sep 23.

    PMID: 24062394DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Laura Dawson, MD

    University Health Network, Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 18, 2009

Study Start

February 1, 2007

Primary Completion

September 26, 2018

Study Completion

September 26, 2018

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations

CA(1)