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

Hepatocellular Carcinoma Clinical Trial

Official title:

Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00923897
• Other study ID #: UHN REB 07-0020-CE
• Status: Completed
• Phase: Phase 2
• Start date: February 2007
• Est. completion date: September 26, 2018

Study information

• Verified date: June 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 26, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatic Metastasis
• Hepatocellular Carcinoma
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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.

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	To measure changes in serum cytokines and proteomics following radiotherapy.		5 years
Secondary	To determine the feasibility of Cone Beam CT for simulation and treatment and optimize image quality offline.		5 years
Secondary	To determine serum marker and radiographic response with 8Gy		5 years