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Mediastinal Lymph Node Dissection in Conjunction With Pulmonary Metastasectomy From Colorectal Cancer

Primary Purpose

Lung Neoplasms, Neoplasm Metastasis, Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Total mediastinal lymph node dissection and pulmonary metastasectomy
Only pulmonary metastasectomy
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Pulmonary neoplasm, Metastasis, colorectal neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age > 18 years
  • Able to give informed consent
  • Willing to be randomized

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Cardiothoracic Surgery, RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lymph node dissection and pulmonary metastasectomy

Pulmonary metastasectomy only

Arm Description

Total mediastinal lymph node dissection and pulmonary metastasectomy from colorectal cancer

Only pulmonary metastasectomy from colorectal cancer

Outcomes

Primary Outcome Measures

5-year overall survival

Secondary Outcome Measures

1-year overall survival
3-year overall survival
1-, 3-, 5-year disease free survival
Number of lymph nodes removed
30- day morbidity
30-day mortality

Full Information

First Posted
April 10, 2017
Last Updated
April 10, 2017
Sponsor
Rigshospitalet, Denmark
Collaborators
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03113318
Brief Title
Mediastinal Lymph Node Dissection in Conjunction With Pulmonary Metastasectomy From Colorectal Cancer
Official Title
Total Mediastinal Lymph Node Dissection in Pulmonary Metastasectomy From Colorectal Cancer - a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Neoplasm Metastasis, Colorectal Cancer
Keywords
Pulmonary neoplasm, Metastasis, colorectal neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lymph node dissection and pulmonary metastasectomy
Arm Type
Experimental
Arm Description
Total mediastinal lymph node dissection and pulmonary metastasectomy from colorectal cancer
Arm Title
Pulmonary metastasectomy only
Arm Type
Active Comparator
Arm Description
Only pulmonary metastasectomy from colorectal cancer
Intervention Type
Procedure
Intervention Name(s)
Total mediastinal lymph node dissection and pulmonary metastasectomy
Intervention Description
Total mediastinal lymph node dissection where all lymph nodes and fatty tissues is removed conjunction with pulmonary metastasectomy
Intervention Type
Procedure
Intervention Name(s)
Only pulmonary metastasectomy
Primary Outcome Measure Information:
Title
5-year overall survival
Time Frame
7-8 years
Secondary Outcome Measure Information:
Title
1-year overall survival
Time Frame
3-4 years
Title
3-year overall survival
Time Frame
4-5 years
Title
1-, 3-, 5-year disease free survival
Time Frame
7-8 years
Title
Number of lymph nodes removed
Time Frame
2-3 years
Title
30- day morbidity
Time Frame
2-3 years
Title
30-day mortality
Time Frame
2-3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 years Able to give informed consent Willing to be randomized Exclusion Criteria: 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
Facility Information:
Facility Name
Department of Cardiothoracic Surgery, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kåre Hornbech, MD
Phone
+4535451212
Email
kaare.hornbech.01@regionh.dk
First Name & Middle Initial & Last Name & Degree
Rene H Petersen, MD
Phone
+4535450525
Email
Rene.horsleben.petersen@regionh.dk

12. IPD Sharing Statement

Citations:
PubMed Identifier
18978560
Citation
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.
Results Reference
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PubMed Identifier
15111187
Citation
Ercan 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.
Results Reference
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PubMed Identifier
12407386
Citation
Saito 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.
Results Reference
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PubMed Identifier
24681037
Citation
Bolukbas 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.
Results Reference
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PubMed Identifier
24442624
Citation
Renaud 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.
Results Reference
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Mediastinal Lymph Node Dissection in Conjunction With Pulmonary Metastasectomy From Colorectal Cancer

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