Colorectal CancerNCT02502630
Microwave Ablation for Pulmonary Metastases From Colorectal Cancer
A study testing microwave ablation in people with Colorectal Cancer, run by The First People's Hospital of Changzhou.
Trial summary
(MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- microwave ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jul 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable pulmonary metastases from colorectal cancer.
- diagnosis by CT, and confirmed by percutaneous puncture biopsy.
- Age range 18-70 years old.
- Eastern Cooperative Oncology Group performance status 0-1.
- Life expectancy of more than 3 months.
- Adequate organ function.
Who cannot join
- Resectable lung metastases.
- Life expectancy less than 3 months
- Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials.
- Coagulopathy with platelet count less than 50000.
- Active infectious disease.
- Age below 18 years.
- Pregnancy of breastfeeding.
About this study
Official title: CT-guided Percutaneous Microwave Ablation for Pulmonary Metastases From Colorectal Cancer
(MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.
Read the detailed description
From June 2010 to June 2015, 48 unresectable lesions in 32 patients with pulmonary metastases from colorectal cancer were selected for CT-guided microwave ablation. Patients were scheduled for a 1 and 3 month CT follow-up to evaluate lesion diameter.We retrospectively evaluated CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- microwave ablation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microwave ablationDevice
pulmonary metastases from colorectal cancer are destructed/ablated using microwave ablation
| Study group | Role | What they receive |
|---|---|---|
| Treated with microwave ablation | Experimental | Patients undergoing MWA for pulmonary metastases from colorectal cancer. Receives: Device: microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: one year
Secondary outcomes (1)
Treatment related adverse events
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJun 2010
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingting Jiang, PD, Study director, The First People's Hospital of Changzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502630
- Sponsor's protocol ID
- CRC-MW-001
- Status last verified
- Aug 2016
- First submitted
- 15 Jul 2015
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Cheng G, Shi L, Qiang W, Wu J, Ji M, Lu Q, Li X, Xu B, Jiang J, Wu C. The safety and efficacy of microwave ablation for the treatment of CRC pulmonary metastases. Int J Hyperthermia. 2018 Jun;34(4):486-491. doi: 10.1080/02656736.2017.1366553. Epub 2017 Nov 16.
PubMed 28847194
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-guided Percutaneous Microwave Ablation for Pulmonary Metastases From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02502630
- Acronym / sponsor ID
- CRC-MW-001
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Jul 2015 (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.
(MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.
Detailed description
From June 2010 to June 2015, 48 unresectable lesions in 32 patients with pulmonary metastases from colorectal cancer were selected for CT-guided microwave ablation. Patients were scheduled for a 1 and 3 month CT follow-up to evaluate lesion diameter.We retrospectively evaluated CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with microwave ablation | Experimental | Device: microwave ablationPatients undergoing MWA for pulmonary metastases from colorectal cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unresectable pulmonary metastases from colorectal cancer.
- diagnosis by CT, and confirmed by percutaneous puncture biopsy.
- Age range 18-70 years old.
- Eastern Cooperative Oncology Group performance status 0-1.
- Life expectancy of more than 3 months.
Key exclusion criteria (7 listed)
- Resectable lung metastases.
- Life expectancy less than 3 months
- Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials.
- Coagulopathy with platelet count less than 50000.
- Active infectious disease.
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 |
|---|---|---|
| microwave ablationpulmonary metastases from colorectal cancer are destructed/ablated using microwave ablation | Device | Treated with microwave ablation |
Primary outcome
Overall Survival (OS)
Time frame: one year
1 secondary outcome
Treatment related adverse events
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Derived from this study: PubMed 28847194Cheng G, Shi L, Qiang W, Wu J, Ji M, Lu Q, Li X, Xu B, Jiang J, Wu C. The safety and efficacy of microwave ablation for the treatment of CRC pulmonary metastases. Int J Hyperthermia. 2018 Jun;34(4):486-491. doi: 10.1080/02656736.2017.1366553. Epub 2017 Nov 16.
- Individual participant dataSharing planned: Undecided
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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.
Jingting Jiang, PD study director
The First People's Hospital of Changzhou
Questions about this trial
What is this clinical trial studying?
A study testing microwave ablation in people with Colorectal Cancer, run by The First People's Hospital of Changzhou.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (OS) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02502630, which also lists 1 linked publication.
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 15 Aug 2016.