Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases

NCT02511522 | Completed Results DMC

• 1 other identifier: HE1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to see whether one dose of palliative radiation therapy directed to the liver in combination with standard BSC might help to reduce liver pain/discomfort due to cancer when compared to getting standard BSC alone.

Conditions

Hepatocellular Carcinoma; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Achieving Significant Improvement of Liver Cancer Pain/Discomfort

  • Proportion of patients achieving improvement of liver cancer pain/discomfort by ≥ 2 points in pain "intensity at worst " on Brief Pain Inventory (BPI) from baseline to day 30.

  30 days

Secondary Outcomes (3)

• Proportion of Patients Alive at Day 90.

  90 days

• Proportion of Patients Achieving a 25% Reduction in Opioid Use at 30 Days (Employing Daily Morphine Equivalence Scale).

  30 days

• Proportion of Patients Achieving Improvement of Liver Cancer Pain/Discomfort by ≥ 2 Points in Pain "Intensity at Worst " AND With no Increase in Opioid Use (Employing Daily Morphine Equivalence Scale) on BPI From Baseline to 30 Days.

  30 days

Study Arms (2)

Best Supportive Care

ACTIVE COMPARATOR

Patients will be randomized 1:1 to receive best supportive care alone

Other: Best Supportive Care

Best Supportive Care + RT 8 Gy/1

EXPERIMENTAL

Patients will be randomized 1:1 to receive best supportive care plus radiation therapy (8 Gy in 1 fraction),

Other: Best Supportive Care; Radiation: Palliative Radiation Therapy

Interventions

Best Supportive Care OTHER

Including analgesics, palliative care and/or pain specialist assessment as needed

Best Supportive Care; Best Supportive Care + RT 8 Gy/1

Palliative Radiation Therapy RADIATION

8 Gy in 1 fraction in whole liver or near whole liver. Including anti-emetic pre-medications

Best Supportive Care + RT 8 Gy/1

Eligibility Criteria

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

You may qualify if:

• A diagnosis of cancer by at least one criterion listed below:
• Pathologically or cytologically proven carcinoma from primary site or site of metastases;
• Pathologically or cytologically proven HCC;
• HCC diagnosed by standard imaging criteria: arterial enhancement and delayed washout on multiphasic computerized tomography (CT) or magnetic resonance imaging (MRI) in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis.
• Largest burden of cancer in the liver is confirmed with CT scan or MRI corresponding to the clinically painful area done within 120 days prior to randomization.
• Diffuse (infiltrative involving \> 50% of the liver), multifocal (\> 10 lesions) or locally advanced cancer (at least one lesion \> 10cm, vascular invasion, or multiple lesions with at least one \> 6cm) involving the liver.
• In the investigator's opinion, patient is unsuitable for or refractory to standard local and regional therapies. For example:
• HCC unsuitable for resection, radiofrequency ablation (RFA), transarterial chemo embolization (TACE) or radical intent, ablative dose stereotactic body radiation therapy (SBRT);
• Colorectal carcinoma metastases unsuitable for resection, RFA or radical intent, ablative dose SBRT (e.g. SBRT, \> 30 Gy in 5 fractions, may be an option for up to 3 metastases \< 5cm each, or up to 5 metastases \< 3 cm each).
• Unsuitable for, high risk for, or refractory to, standard systemic chemotherapy or targeted therapy (e.g. sorafenib).
• Patient reports moderate or severe pain/discomfort prior to the baseline evaluation and this pain is considered "stable" over a period of up to 7 days prior to randomization.
• Definition of moderate pain:
• Patient reports level of 4-6 (on a BPI scale from 0 to 10) pain or discomfort "at its worst in the past 24 hours", occurring in the right upper quadrant of the abdomen, the upper abdomen and/or referred to the right shoulder, attributable to liver cancer.
• Definition of severe pain:
• Patient reports level of 7-10 (on a BPI scale from 0 to 10) pain or discomfort "at its worst in the past 24 hours", occurring in the right upper quadrant of the abdomen, the upper abdomen and/or referred to the right shoulder, attributable to liver cancer.

You may not qualify if:

• Prior radiotherapy to the upper abdomen that would result in substantial overlap of the irradiated volume (e.g. \> 50% of liver receiving \> 24 Gy in 2 Gy equivalent dose);
• Prior selective internal radiotherapy directed to the liver or hepatic arterial yttrium therapy, at any time.
• Cholangitis or acute bacterial infection requiring intravenous antibiotics within 28 days prior to study entry.
• Radiographic evidence of intrabiliary cancer within the common or main branches of the biliary system, \< 4 months prior to randomization.
• Child-Pugh score greater than C10 (a score of C10 is allowed).
• Chemotherapy or TACE administered within the past 4 weeks.
• Targeted therapy (e.g. Sorafenib) received within the past 2 weeks.
• Plans for chemotherapy, targeted therapy or TACE in the next 4 weeks.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead

Study Sites (7)

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

Centre hospitalier regional de Trois-Rivieres

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Related Publications (1)

• Dawson LA, Ringash J, Fairchild A, Stos P, Dennis K, Mahmud A, Stuckless TL, Vincent F, Roberge D, Follwell M, Wong RKW, Jonker DJ, Knox JJ, Zimmermann C, Wong P, Barry AS, Gaudet M, Wong RKS, Purdie TG, Tu D, O'Callaghan CJ. Palliative radiotherapy versus best supportive care in patients with painful hepatic cancer (CCTG HE1): a multicentre, open-label, randomised, controlled, phase 3 study. Lancet Oncol. 2024 Oct;25(10):1337-1346. doi: 10.1016/S1470-2045(24)00438-8. Epub 2024 Sep 5.

  PMID: 39245060 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Dr. Chris O'Callaghan
• Organization: Canadian Cancer Trials Group

cocallaghan@ctg.queensu.ca

6135336430

Study Officials

• Laura Ann Dawson

  Univ. Health Network-Princess Margaret Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 30, 2015
• Study Start: December 11, 2015
• Primary Completion: October 26, 2022
• Study Completion: October 2, 2024
• Last Updated: October 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)