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

Total Mediastinal Lymph Node Dissection in Pulmonary Metastasectomy From Colorectal Cancer - a Randomized, Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03113318
Enrollment
200
Registered
2017-04-13
Start date
2015-10-31
Completion date
2022-10-31
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Lung Neoplasms, Neoplasm Metastasis

Keywords

Pulmonary neoplasm, Metastasis, colorectal neoplasm

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: 1. Systemic mediastinal lymphadenectomy during pulmonary metastasectomy with curative intent for colorectal carcinoma (CRC) is feasible and safe. 2. 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.

Interventions

PROCEDURETotal mediastinal lymph node dissection and pulmonary metastasectomy

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

PROCEDUREOnly pulmonary metastasectomy

Sponsors

M.D. Anderson Cancer Center
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
5-year overall survival7-8 years

Secondary

MeasureTime frame
3-year overall survival4-5 years
1-, 3-, 5-year disease free survival7-8 years
1-year overall survival3-4 years
30- day morbidity2-3 years
30-day mortality2-3 years
Number of lymph nodes removed2-3 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026