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

NCT03113318 | Unknown

• 1 other identifier: Khornbech
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms; Neoplasm Metastasis; Colorectal Cancer

Keywords

Pulmonary neoplasm; Metastasis; colorectal neoplasm

Outcome Measures

Primary Outcomes (1)

• 5-year overall survival

  7-8 years

Secondary Outcomes (6)

• 1-year overall survival

  3-4 years

• 3-year overall survival

  4-5 years

• 1-, 3-, 5-year disease free survival

  7-8 years

• Number of lymph nodes removed

  2-3 years

• 30- day morbidity

  2-3 years

Study Arms (2)

Lymph node dissection and pulmonary metastasectomy

EXPERIMENTAL

Total mediastinal lymph node dissection and pulmonary metastasectomy from colorectal cancer

Procedure: Total mediastinal lymph node dissection and pulmonary metastasectomy

Pulmonary metastasectomy only

ACTIVE COMPARATOR

Only pulmonary metastasectomy from colorectal cancer

Procedure: Only pulmonary metastasectomy

Interventions

Total mediastinal lymph node dissection and pulmonary metastasectomy PROCEDURE

Total mediastinal lymph node dissection where all lymph nodes and fatty tissues is removed conjunction with pulmonary metastasectomy

Lymph node dissection and pulmonary metastasectomy

Only pulmonary metastasectomy PROCEDURE

Pulmonary metastasectomy only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

Department of Cardiothoracic Surgery, Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

RECRUITING

Related Publications (5)

• 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.

  PMID: 18978560 BACKGROUND

• 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.

  PMID: 15111187 BACKGROUND

• 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.

  PMID: 12407386 BACKGROUND

• 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.

  PMID: 24681037 BACKGROUND

• 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.

  PMID: 24442624 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2022
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

DK (1)