Palliative Radiotherapy (RT) for Liver Metastases (Mets) and Hepatocellular Carcinoma (HCC)(COLD 4)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00923897
First received: June 16, 2009
Last updated: January 3, 2014
Last verified: January 2014

June 16, 2009
January 3, 2014
February 2007
February 2014   (final data collection date for primary outcome measure)
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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00923897 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To measure changes in serum cytokines and proteomics following radiotherapy. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To determine the feasibility of Cone Beam CT for simulation and treatment and optimize image quality offline. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To determine serum marker and radiographic response with 8Gy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Determine change in EORTC QLQ-C30 & FACT-Hep for patients with locally advanced HCC/hepatic metastases treated with 8Gy,toxicity of treatment evaluated by the CTC 3.0 toxicity score,serum marker and radiographic response with 8Gy,feasibility of [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Palliative Radiotherapy (RT) for Liver Metastases (Mets) and Hepatocellular Carcinoma (HCC)(COLD 4)
Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases

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.

The liver is one of the most common sites with tumour involvement, including both primary and metastatic disease. Gastrointestinal tumours, breast, lung and melanoma are the most common primary sites for hepatic metastases. Hepatocellular carcinoma(HCC) is the sixth most common cancer worldwide, with over 600,000 new cases diagnosed per year. It is the third most common cause of cancer related death.Although, predominately a disease in Asia and sub-Saharan Africa, the incidence of HCC is increasing in North America. The use of radiation in unresectable hepatocellular carcinomas, as well as hepatic metastases, for palliation is uncommon in clinical practice.

This may be because there is a prevailing perception that radiation to the liver will inevitably lead to radiation induced liver disease (RILD). However, several single institution, predominantly retrospective studies, have demonstrated effective palliation for locally advanced HCC as well as hepatic metastases with minimal toxicity.In this study, palliative radiotherapy (RT), delivered in one fraction of 8Gy, will be given to symptomatic patients who are not candidates for radical treatment. We hypothesize that palliative RT will provide symptomatic relief to a large fraction of the patients, with both primary and metastatic disease. We also expect minimal toxicities at this treatment dose.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Hepatocellular Carcinoma
  • Hepatic Metastasis
Radiation: Palliative RT
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.
Experimental: RT for Liver Mets and HCC
Intervention: Radiation: Palliative RT
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00923897
UHN REB 07-0020-CE
Yes
University Health Network, Toronto
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Laura Dawson, MD University Health Network, Princess Margaret Hospital
University Health Network, Toronto
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP