Metastatic Colorectal Liver CancerNCT01048216
Partial Liver Radiotherapy for Unresectable Liver Metastases
A study testing radiation therapy in people with Metastatic Colorectal Liver Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Liver Cancer
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2006to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Diana Tait contact
Maria Hawkins contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Maria Hawkins, 020 8661 8915
Diana Tait
About this study
Official title: Partial Liver Radiotherapy for Patients With Unresectable Colorectal Liver Metastases
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.
- Conditions
- Metastatic Colorectal Liver Cancer
- Being tested
- radiation therapy
- Keywords
- colorectal liver cancer, metastatic, radiation therapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
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
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer and determine its safety
Secondary outcomes (3)
To evaluate local control rate within irradiated fields
To assess failure patterns and survival of patients treated with conformal liver radiation
Set up verification with cone-beam CT (OBI on Boar Imager)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startNov 2006
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Liver CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Diana Tait, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048216
- Sponsor's protocol ID
- CCR2772
- Status last verified
- Jan 2010
- First submitted
- 12 Jan 2010
- Last updated
- 13 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Liver Radiotherapy for Patients With Unresectable Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT01048216
- Acronym / sponsor ID
- CCR2772
- Conditions
- Metastatic Colorectal Liver Cancer
- Keywords
- colorectal liver cancer, metastatic, radiation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapyCT 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 | Radiation | – |
Primary outcome
To evaluate feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer and determine its safety
3 secondary outcomes
To evaluate local control rate within irradiated fields
To assess failure patterns and survival of patients treated with conformal liver radiation
Set up verification with cone-beam CT (OBI on Boar Imager)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Tait contact
Maria Hawkins contact
Diana Tait principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiation therapy in people with Metastatic Colorectal Liver Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Tait (020 8661 8915), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate feasibility of conformal radiation therapy in patients with metastatic colorectal liver cancer and determine its safety. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.