CClinicalTrials.gg
Status unknownNCT01048216Updated Jan 13, 2010

Partial Liver Radiotherapy for Unresectable Liver Metastases

An interventional study of radiation therapy in Metastatic Colorectal Liver Cancer, sponsored by Royal Marsden NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-13.

Sponsored by Royal Marsden NHS Foundation Trust · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to treat tumors in the liver that cannot be removed surgically and chemotherapy cannot control these tumors, using radiation therapy and a more precise delivery than has been used before.

Read the detailed description

The purpose of this study is to evaluate safety and feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer. This study would also evaluate local control rate within irradiated area and to assess failure patterns and survival of patients treated with conformal liver radiation.

02

Conditions studied

  • Metastatic Colorectal Liver Cancer

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Keywords

  • colorectal liver cancer
  • metastatic
  • radiation therapy
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 18 is below the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

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Lead sponsor

Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • liver metastases unequivocally seen on contrast enhanced CT and/or MRI from colon or rectal cancer, previously confirmed pathologically as adenocarcinoma
  • either 1) the tumor must be unresectable, 2) the patient must be medically inoperable, or 3) extra-hepatic metastases are present (making hepatic surgery an inappropriate treatment option)
  • good performance status (0-1)
  • Age > 18 years. Adult patients of all ages, both sexes and all races will be included in this study. Female patients within reproductive years may not be, nor become, pregnant during participation in this study
  • life expectancy > 3 months

Exclusion criteria

Exclusion Criteria:

  • patients with active hepatitis or clinically significant liver failure
  • patients receiving anticoagulation treatment with warfarin or heparin
  • prior radiation therapy to the right upper abdomen, precluding re-irradiation of the liver
  • clinically apparent ascites
  • central nervous system metastases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Enrollment
18 participants (estimated)

Interventions

  • Radiationradiation therapy

    CT based 3D treatment shall be used for all patients. There will be 10 equal fractions delivered over 2 weeks. The prescribed dose and fraction will be individualised according to effective liver volume treated

06

What researchers measure

Primary outcomes

  1. To evaluate feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer and determine its safety

Secondary outcomes

  1. To evaluate local control rate within irradiated fields

  2. To assess failure patterns and survival of patients treated with conformal liver radiation

  3. Set up verification with cone-beam CT (OBI on Boar Imager)

07

Study locations

1 of 1 sites recruiting
  • Royal Marsden NHS Foundation Trust
    Sutton, Surrey SM2 5PT, United Kingdom
    • Maria Hawkins · Contact · 020 8661 8915
    • Diana Tait · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01048216
Lead sponsor
Royal Marsden NHS Foundation Trust
First posted
Jan 13, 2010
Start date
Nov 2006
Primary completion
Jun 2008 (estimated)
Completion
Jun 2008 (estimated)
Last update
Jan 13, 2010

Study contacts

Diana Tait
Contact
020 8661 8915
Maria Hawkins
Contact
020 8661 8915
Diana Tait
principal investigator · Royal Marsden NHS Foundation Trust
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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