Metastatic Colo-rectal CancerLOTCOLNCT01867918
LOTCOL Study: Local Treatment of Colo-rectal Liver Met
A study testing Radiofrequency ablation, microwave, radiation therapy and Standard Chemotherapy in people with Metastatic Colo-rectal Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
In this study the investigators will include colo-rectal cancer (CRC) patients starting last line of standard palliative chemotherapy. Eligible patients include patients with KRAS mutation starting line or KRAS wild type starting line treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colo-rectal Cancer
- What is being tested?
- Radiofrequency ablation, microwave, radiation therapy and Standard Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Dec 2016
- 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
- Histologically verified adenocarcinoma of colon or rectum
- Ambulatory with an ECOG performance status 0-2
- At least 18 years of age
- Non-resectable liver metastases
- Progressive disease on or within 4 months after 1.line chemotherapy for KRAS mutant or after 2.line chemotherapy in KRAS wild type patients
- 1-4 liver metastases with largest diameter of up to 6 cm on CT-scan
Show all 18Show fewer
- Up to 20 lesions in liver with no more than 4 lesions larger than 4 cm
- The patients will start 2./3. line chemotherapy (KRAS mutant/KRAS wt)
- Laboratory values as the following:
- ANC ³ 1.5 x 109/L
- Platelets ³ 100 x 109/L
- Hb ³ 9g/dL
- Creatinine £ 2x upper limit of normal
- Bilirubin < 2.0x the upper limit of normal
- ASAT and ALAT £ 5x the upper limit of normal
- Albumin levels > 30 g/L
- INR<1.3
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations
Who cannot join
- Previous treatment with 2. or 3. line chemotherapy (KRAS mutant/KRAS wt)
- History of prior metastatic disease the last 3 years
- History of CNS or bone metastases
- Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
- Largest liver mets >6 cm, more than 4 liver lesions >4 cm
- Pulmonary mets>3 cm
Show all 9Show fewer
- Lymph node mets >2.5 cm
- Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
- Any reason why, in the opinion of the investigator, the patient should not participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study With Palliative Chemotherapy With or Without Local Treatment of Liver Metastases in Patients With Colo-rectal Cancer
In this study the investigators will include colo-rectal cancer (CRC) patients starting last line of standard palliative chemotherapy. Eligible patients include patients with KRAS mutation starting line or KRAS wild type starting line treatment. Standard treatment today for these patients is chemotherapy only and median overall survival (OS) is about 10 months. The hypothesis is that local treatment in addition to systemic treatment will increase time to progression, progression free survival and overall survival compared to patients who receive systemic chemotherapy only. The investigators experience with local treatment of liver metastases in CRC patients is that side-effects of treatment in general are minor, although gastric bleeding have been observed after stereotactic body radiation therapy.
- Conditions
- Metastatic Colo-rectal Cancer
- Being tested
- Radiofrequency ablation, microwave, radiation therapy, Standard Chemotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation, microwave, radiation therapyProcedure or surgery
Radiofrequency ablation Microwave ablation Radiation therapy
Standard ChemotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Cheomotherapy and local treatment | Experimental | Standard chemotherapy + local treatment Receives: Procedure: Radiofrequency ablation, microwave, radiation therapy |
| Cheomotherapy | Placebo comparator | Standard chemotherapy Receives: Drug: Standard Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival from time of randomization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Insuffisient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svein Dueland, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867918
- Sponsor's protocol ID
- 2012/1392 REK South East C
- Other IDs
- 2012/1392 REK South East C
- Acronym
- LOTCOL
- Status last verified
- Jan 2017
- First submitted
- 3 May 2013
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study With Palliative Chemotherapy With or Without Local Treatment of Liver Metastases in Patients With Colo-rectal Cancer
- ClinicalTrials.gov ID
- NCT01867918
- Acronym / sponsor ID
- LOTCOL / 2012/1392 REK South East C
- Conditions
- Metastatic Colo-rectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insuffisient recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Jun 2013 (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.
In this study the investigators will include colo-rectal cancer (CRC) patients starting last line of standard palliative chemotherapy. Eligible patients include patients with KRAS mutation starting line or KRAS wild type starting line treatment. Standard treatment today for these patients is chemotherapy only and median overall survival (OS) is about 10 months. The hypothesis is that local treatment in addition to systemic treatment will increase time to progression, progression free survival and overall survival compared to patients who receive systemic chemotherapy only. The investigators experience with local treatment of liver metastases in CRC patients is that side-effects of treatment in general are minor, although gastric bleeding have been observed after stereotactic body radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cheomotherapy and local treatment | Experimental | Procedure: Radiofrequency ablation, microwave, radiation therapyStandard chemotherapy + local treatment |
| Cheomotherapy | Placebo comparator | Drug: Standard ChemotherapyStandard chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically verified adenocarcinoma of colon or rectum
- Ambulatory with an ECOG performance status 0-2
- At least 18 years of age
- Non-resectable liver metastases
- Progressive disease on or within 4 months after 1.line chemotherapy for KRAS mutant or after 2.line chemotherapy in KRAS wild type patients
Key exclusion criteria (9 listed)
- Previous treatment with 2. or 3. line chemotherapy (KRAS mutant/KRAS wt)
- History of prior metastatic disease the last 3 years
- History of CNS or bone metastases
- Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
- Largest liver mets >6 cm, more than 4 liver lesions >4 cm
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 |
|---|---|---|
| Radiofrequency ablation, microwave, radiation therapyRadiofrequency ablation Microwave ablation Radiation therapy | Procedure or surgery | Cheomotherapy and local treatment |
| Standard Chemotherapy | Drug | Cheomotherapy |
Primary outcome
Overall survival from time of randomization
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Insuffisient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
Related trials for Metastatic Colo-rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation, microwave, radiation therapy and Standard Chemotherapy in people with Metastatic Colo-rectal Cancer, run by Oslo University Hospital at 1 site in Norway.
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 18 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 Jan 2017. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Insuffisient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival from time of randomization (time frame: 6 months). 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 9 Jan 2017.