Lung NeoplasmsNCT03113318
Mediastinal Lymph Node Dissection in Conjunction With Pulmonary Metastasectomy From Colorectal Cancer
A study testing Total mediastinal lymph node dissection and pulmonary metastasectomy and Only pulmonary metastasectomy in people with Lung Neoplasms and Neoplasm Metastasis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
To study whether or not total mediastinal lymph node dissection in conjunction with pulmonary metastasectomy from colorectal cancer is associated with improved survival compared to pulmonary metastasectomy only. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasms, Neoplasm Metastasis, Colorectal Cancer
- What is being tested?
- Total mediastinal lymph node dissection and pulmonary metastasectomy and Only pulmonary metastasectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Oct 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Able to give informed consent
- Willing to be randomized
Who cannot join
- Previous mediastinal lymphadenectomy
- Previous pulmonary metastasectomy
- Evidence of other metastasetic disease
- Primary tumor is not under control
- Five metastases or more
- If final histologic examination of the resected lung lesion(s) reveals other histology than colorectal metastasis
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Cardiothoracic Surgery, Rigshospitalet
Copenhagen, Copenhagen, 2100
Kåre Hornbech, MD, +4535451212, kaare.hornbech.01@regionh.dk
Rene H Petersen, MD, +4535450525, Rene.horsleben.petersen@regionh.dk
About this study
Official title: Total Mediastinal Lymph Node Dissection in Pulmonary Metastasectomy From Colorectal Cancer - a Randomized, Controlled Trial
To study whether or not total mediastinal lymph node dissection in conjunction with pulmonary metastasectomy from colorectal cancer is associated with improved survival compared to pulmonary metastasectomy only.
Read the detailed description
The question of lymph node sampling and/or involvement in pulmonary metastasectomy remains controversial. The performance of lymph node dissection during pulmonary metastasectomy is infrequent and varies between institutions. Of all the patients in The International Registry of Lung Metastases only 4,6% of patients underwent lymph node dissection. In a recent survey by Internullo and colleagues amongst the members of European Society of Thoracic Surgeons 55% perform mediastinal lymph node sampling whereas 33% perform no nodal sampling at all. The rate of lymph node involvement varies between primary tumours.
Several studies from groups that systematically perform mediastinal lymph node dissection in conjunction with pulmonary metastasectomy have been published and in all studies the presence of lymph node metastasis emerges as an ominous prognostic factor. Ercan and colleagues found a 3-year survival of 69% for patients without lymph node involvement versus 38% in patients with positive lymph nodes. Saito and colleagues reported a 5-year survival of 53,6 for patients without hilar or mediastinal node involvement versus 6,2% at 4 years for patients with positive nodes. Bölükbas and colleagues reported a 5-year survival of 59% for patients without lymph node involvement in contrast to 23% for patients with lymph node involvement.
The rate of lymph node involvement is reported between 20-43% and risk factors for lymph node involvement include 2 or more metastases, prior liver metastases, rectum cancer and size of metastases .
Most of the above mentioned authors are in favor of mediastinal lymphadenectomy but also stress that the evidence available is not solid enough to make firm recommendations. In conclusion the literature is quite limited and of low-level evidence.
In remains unclear whether the complete removal of mediastinal lymph nodes is associated with a survival benefit or merely allows for a more accurate postoperative staging and guidance for additional oncological treatment. Thus, the aim of the following proposed study is to examine whether or not systemic lymph node dissection during pulmonary metastasectomy is associated with a survival benefit.
Hypothesis:
- Systemic mediastinal lymphadenectomy during pulmonary metastasectomy with curative intent for colorectal carcinoma (CRC) is feasible and safe.
- Systemic mediastinal lymphadenectomy during pulmonary metastasectomy with curative intent for CRC is associated with improved survival compared to only pulmonary metastasectomy.
Design:
Prospective, randomized, controlled trial. No lymph node dissection versus systemic mediastinal lymph node dissection with en-bloc resection of lymph nodes and fatty tissue in station 2,4,7,8, 9 and 10 on the right side and 5,6,7,8, 9 and 10 on the left side during pulmonary metastasectomy for CRC.
- Conditions
- Lung Neoplasms, Neoplasm Metastasis, Colorectal Cancer
- Being tested
- Total mediastinal lymph node dissection and pulmonary metastasectomy, Only pulmonary metastasectomy
- Keywords
- Pulmonary neoplasm, Metastasis, colorectal neoplasm
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total mediastinal lymph node dissection and pulmonary metastasectomyProcedure or surgery
Total mediastinal lymph node dissection where all lymph nodes and fatty tissues is removed conjunction with pulmonary metastasectomy
Only pulmonary metastasectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Lymph node dissection and pulmonary metastasectomy | Experimental | Total mediastinal lymph node dissection and pulmonary metastasectomy from colorectal cancer Receives: Procedure: Total mediastinal lymph node dissection and pulmonary metastasectomy |
| Pulmonary metastasectomy only | Active comparator | Only pulmonary metastasectomy from colorectal cancer Receives: Procedure: Only pulmonary metastasectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
Measured: 7-8 years
Secondary outcomes (6)
1-year overall survival
Measured: 3-4 years
3-year overall survival
Measured: 4-5 years
1-, 3-, 5-year disease free survival
Measured: 7-8 years
Number of lymph nodes removed
Measured: 2-3 years
30- day morbidity
Measured: 2-3 years
30-day mortality
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startOct 2015
- Primary completionOct 2018 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Kåre Hornbech, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113318
- Sponsor's protocol ID
- Khornbech
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Internullo E, Cassivi SD, Van Raemdonck D, Friedel G, Treasure T; ESTS Pulmonary Metastasectomy Working Group. Pulmonary metastasectomy: a survey of current practice amongst members of the European Society of Thoracic Surgeons. J Thorac Oncol. 2008 Nov;3(11):1257-66. doi: 10.1097/JTO.0b013e31818bd9da.
PubMed 18978560Ercan S, Nichols FC 3rd, Trastek VF, Deschamps C, Allen MS, Miller DL, Schleck CD, Pairolero PC. Prognostic significance of lymph node metastasis found during pulmonary metastasectomy for extrapulmonary carcinoma. Ann Thorac Surg. 2004 May;77(5):1786-91. doi: 10.1016/S0003-4975(03)01200-1.
PubMed 15111187Saito Y, Omiya H, Kohno K, Kobayashi T, Itoi K, Teramachi M, Sasaki M, Suzuki H, Takao H, Nakade M. Pulmonary metastasectomy for 165 patients with colorectal carcinoma: A prognostic assessment. J Thorac Cardiovasc Surg. 2002 Nov;124(5):1007-13. doi: 10.1067/mtc.2002.125165.
PubMed 12407386Bolukbas S, Sponholz S, Kudelin N, Eberlein M, Schirren J. Risk factors for lymph node metastases and prognosticators of survival in patients undergoing pulmonary metastasectomy for colorectal cancer. Ann Thorac Surg. 2014 Jun;97(6):1926-32. doi: 10.1016/j.athoracsur.2014.02.026. Epub 2014 Mar 28.
PubMed 24681037Renaud S, Alifano M, Falcoz PE, Magdeleinat P, Santelmo N, Pages O, Massard G, Regnard JF. Does nodal status influence survival? Results of a 19-year systematic lymphadenectomy experience during lung metastasectomy of colorectal cancer. Interact Cardiovasc Thorac Surg. 2014 Apr;18(4):482-7. doi: 10.1093/icvts/ivt554. Epub 2014 Jan 16.
PubMed 24442624
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Mediastinal Lymph Node Dissection in Pulmonary Metastasectomy From Colorectal Cancer - a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03113318
- Acronym / sponsor ID
- Khornbech
- Conditions
- Lung Neoplasms, Neoplasm Metastasis, Colorectal Cancer
- Keywords
- Pulmonary neoplasm, Metastasis, colorectal neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Oct 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 13 Apr 2017 (actual)
- 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.
To study whether or not total mediastinal lymph node dissection in conjunction with pulmonary metastasectomy from colorectal cancer is associated with improved survival compared to pulmonary metastasectomy only.
Detailed description
The question of lymph node sampling and/or involvement in pulmonary metastasectomy remains controversial. The performance of lymph node dissection during pulmonary metastasectomy is infrequent and varies between institutions. Of all the patients in The International Registry of Lung Metastases only 4,6% of patients underwent lymph node dissection. In a recent survey by Internullo and colleagues amongst the members of European Society of Thoracic Surgeons 55% perform mediastinal lymph node sampling whereas 33% perform no nodal sampling at all. The rate of lymph node involvement varies between primary tumours.
Several studies from groups that systematically perform mediastinal lymph node dissection in conjunction with pulmonary metastasectomy have been published and in all studies the presence of lymph node metastasis emerges as an ominous prognostic factor. Ercan and colleagues found a 3-year survival of 69% for patients without lymph node involvement versus 38% in patients with positive lymph nodes. Saito and colleagues reported a 5-year survival of 53,6 for patients without hilar or mediastinal node involvement versus 6,2% at 4 years for patients with positive nodes. Bölükbas and colleagues reported a 5-year survival of 59% for patients without lymph node involvement in contrast to 23% for patients with lymph node involvement.
The rate of lymph node involvement is reported between 20-43% and risk factors for lymph node involvement include 2 or more metastases, prior liver metastases, rectum cancer and size of metastases .
Most of the above mentioned authors are in favor of mediastinal lymphadenectomy but also stress that the evidence available is not solid enough to make firm recommendations. In conclusion the literature is quite limited and of low-level evidence.
In remains unclear whether the complete removal of mediastinal lymph nodes is associated with a survival benefit or merely allows for a more accurate postoperative staging and guidance for additional oncological treatment. Thus, the aim of the following proposed study is to examine whether or not systemic lymph node dissection during pulmonary metastasectomy is associated with a survival benefit.
Hypothesis:
- Systemic mediastinal lymphadenectomy during pulmonary metastasectomy with curative intent for colorectal carcinoma (CRC) is feasible and safe.
- Systemic mediastinal lymphadenectomy during pulmonary metastasectomy with curative intent for CRC is associated with improved survival compared to only pulmonary metastasectomy.
Design:
Prospective, randomized, controlled trial. No lymph node dissection versus systemic mediastinal lymph node dissection with en-bloc resection of lymph nodes and fatty tissue in station 2,4,7,8, 9 and 10 on the right side and 5,6,7,8, 9 and 10 on the left side during pulmonary metastasectomy for CRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymph node dissection and pulmonary metastasectomy | Experimental | Procedure: Total mediastinal lymph node dissection and pulmonary metastasectomyTotal mediastinal lymph node dissection and pulmonary metastasectomy from colorectal cancer |
| Pulmonary metastasectomy only | Active comparator | Procedure: Only pulmonary metastasectomyOnly pulmonary metastasectomy from colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Able to give informed consent
- Willing to be randomized
Key exclusion criteria (6 listed)
- Previous mediastinal lymphadenectomy
- Previous pulmonary metastasectomy
- Evidence of other metastasetic disease
- Primary tumor is not under control
- Five metastases or more
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 |
|---|---|---|
| Total mediastinal lymph node dissection and pulmonary metastasectomyTotal mediastinal lymph node dissection where all lymph nodes and fatty tissues is removed conjunction with pulmonary metastasectomy | Procedure or surgery | Lymph node dissection and pulmonary metastasectomy |
| Only pulmonary metastasectomy | Procedure or surgery | Pulmonary metastasectomy only |
Primary outcome
5-year overall survival
Time frame: 7-8 years
6 secondary outcomes
1-year overall survival
Time frame: 3-4 years
3-year overall survival
Time frame: 4-5 years
1-, 3-, 5-year disease free survival
Time frame: 7-8 years
Number of lymph nodes removed
Time frame: 2-3 years
30- day morbidity
Time frame: 2-3 years
30-day mortality
Time frame: 2-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Background: PubMed 18978560Internullo E, Cassivi SD, Van Raemdonck D, Friedel G, Treasure T; ESTS Pulmonary Metastasectomy Working Group. Pulmonary metastasectomy: a survey of current practice amongst members of the European Society of Thoracic Surgeons. J Thorac Oncol. 2008 Nov;3(11):1257-66. doi: 10.1097/JTO.0b013e31818bd9da.
- Background: PubMed 15111187Ercan S, Nichols FC 3rd, Trastek VF, Deschamps C, Allen MS, Miller DL, Schleck CD, Pairolero PC. Prognostic significance of lymph node metastasis found during pulmonary metastasectomy for extrapulmonary carcinoma. Ann Thorac Surg. 2004 May;77(5):1786-91. doi: 10.1016/S0003-4975(03)01200-1.
- Background: PubMed 12407386Saito Y, Omiya H, Kohno K, Kobayashi T, Itoi K, Teramachi M, Sasaki M, Suzuki H, Takao H, Nakade M. Pulmonary metastasectomy for 165 patients with colorectal carcinoma: A prognostic assessment. J Thorac Cardiovasc Surg. 2002 Nov;124(5):1007-13. doi: 10.1067/mtc.2002.125165.
- Background: PubMed 24681037Bolukbas S, Sponholz S, Kudelin N, Eberlein M, Schirren J. Risk factors for lymph node metastases and prognosticators of survival in patients undergoing pulmonary metastasectomy for colorectal cancer. Ann Thorac Surg. 2014 Jun;97(6):1926-32. doi: 10.1016/j.athoracsur.2014.02.026. Epub 2014 Mar 28.
- Background: PubMed 24442624Renaud S, Alifano M, Falcoz PE, Magdeleinat P, Santelmo N, Pages O, Massard G, Regnard JF. Does nodal status influence survival? Results of a 19-year systematic lymphadenectomy experience during lung metastasectomy of colorectal cancer. Interact Cardiovasc Thorac Surg. 2014 Apr;18(4):482-7. doi: 10.1093/icvts/ivt554. Epub 2014 Jan 16.
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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.
Department of Cardiothoracic Surgery, Rigshospitalet
Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total mediastinal lymph node dissection and pulmonary metastasectomy and Only pulmonary metastasectomy in people with Lung Neoplasms and Neoplasm Metastasis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 6 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 Apr 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 Denmark. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival (time frame: 7-8 years). 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 NCT03113318, which also lists 5 linked publications.
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 Apr 2017.