Back to resultsEsophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases (Node)
Primary Purpose
Cancer, Squamous Cell Carcinoma, Adenocarcinoma
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
esophagectomy with three-field lymphnode dissection
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring three-field lymphadenectomy, cervical metastases, esophagectomy
Eligibility Criteria
Inclusion Criteria:
- Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus.
- Surgical resectable carcinoma (T1-4a, N1-3) (table 1)
- Histologically/ cytologically proven resectable cervical lymph node metastases level III and/ or IV
- Age ≥ 18
- European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- Written informed consent
Exclusion Criteria:
- Distant metastases
- Esophageal carcinoma < 3 cm beneath UES
- Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III)
- Former radiotherapy or chemotherapy for esophageal carcinoma
- Former radiotherapy precluding radiotherapy according the CROSS protocol
- Inadequate pulmonary function disabling transthoracic resection
- >10% loss of weight in the last six months
- Previous neck dissection
- New York heart association class III/IV and no history of active angina. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks
Sites / Locations
- UMC Utrecht
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
surgery
Arm Description
esophagectomy with three-field lymphnode dissection
Outcomes
Primary Outcome Measures
Safety measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
Safety is measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
Secondary Outcome Measures
mortality
in-hospital mortality and 30- and 60 day mortality (absolute numbers/ percentages)
survival
5 year overall- and disease free survival.
quality of life measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)
QoL is measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)
operation related events 1
duration of surgery (minutes)
operation related events 2
reason for prolongation of surgery if applicable
operation related events 3
unexpected events/ complications
operation related events 4
bloodloss (ml) reason for conversion if applicable.
operation related events 5
reason for conversion if applicable.
postoperative recovery
duration of intubation (days), length of ICU/ MCU stay(days), length of hospital stay (days),
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02426879
Brief Title
Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases
Acronym
Node
Official Title
Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 11, 2015 (Actual)
Primary Completion Date
January 25, 2021 (Actual)
Study Completion Date
January 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There is no world-wide consensus on the oncological benefit versus increased morbidity associated with three field lymphadenectomy in patients with esophageal cancer and cervical lymph node metastases. In Asian countries, esophagectomy is commonly combined with a three field lymphadenectomy, including resection of cervical, thoracic and abdominal lymph nodes. However, in Western countries patients with cervical lymph node metastases are generally precluded from curative treatment.
Detailed Description
Objective: To assess the safety and feasibility of curative esophagectomy combined with three field lymphadenectomy after chemo-radiation in Western patients with resectable thoracic esophageal carcinoma and cervical lymph node metastases. Secondary objective is to determine the effect on survival and recurrence.
Study design: Mono centre prospective phase II single-arm feasibility study. Study population: Western patients diagnosed with resectable (cT1-4a, N1-3) intra thoracic esophageal carcinoma with histological or cytological proven cervical lymph node metastases in level III and/ or IV.
Intervention: Transthoracic esophageal resection combined with three field lymphadenectomy after neoadjuvant chemo-radiation.
Main study parameters/ endpoints: Primary outcome is the percentage of overall surgical complications grade 3b and higher as stated by the Modified Clavien-Dindo classification. Secondary outcomes are mortality, operation related events and postoperative recovery, including quality of life, disease free survival, overall survival and if applicable the location of recurrent disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Squamous Cell Carcinoma, Adenocarcinoma, Malignancy
Keywords
three-field lymphadenectomy, cervical metastases, esophagectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgery
Arm Type
Other
Arm Description
esophagectomy with three-field lymphnode dissection
Intervention Type
Procedure
Intervention Name(s)
esophagectomy with three-field lymphnode dissection
Intervention Description
robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection
Primary Outcome Measure Information:
Title
Safety measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
Description
Safety is measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
mortality
Description
in-hospital mortality and 30- and 60 day mortality (absolute numbers/ percentages)
Time Frame
5 years
Title
survival
Description
5 year overall- and disease free survival.
Time Frame
5 years
Title
quality of life measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)
Description
QoL is measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)
Time Frame
10 years
Title
operation related events 1
Description
duration of surgery (minutes)
Time Frame
5 years
Title
operation related events 2
Description
reason for prolongation of surgery if applicable
Time Frame
5 years
Title
operation related events 3
Description
unexpected events/ complications
Time Frame
5 years
Title
operation related events 4
Description
bloodloss (ml) reason for conversion if applicable.
Time Frame
5 years
Title
operation related events 5
Description
reason for conversion if applicable.
Time Frame
5 years
Title
postoperative recovery
Description
duration of intubation (days), length of ICU/ MCU stay(days), length of hospital stay (days),
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
pathology results 1
Description
pTNM stage
Time Frame
5 years
Title
pathology results 2
Description
site of tumour
Time Frame
5 years
Title
pathology results 3
Description
length of tumour
Time Frame
5 years
Title
pathology results 4
Description
type of tumour
Time Frame
5 years
Title
pathology results 5
Description
gradation of tumour
Time Frame
5 years
Title
pathology results 6
Description
margins of resection (R0, R1, R2)
Time Frame
5 years
Title
pathology results 7
Description
mandard score
Time Frame
5 years
Title
pathology results 8
Description
lymphnode status
Time Frame
5 years
Title
pathology results 9
Description
vaso-invasion
Time Frame
5 years
Title
pathology results 10
Description
perineural growth
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus.
Surgical resectable carcinoma (T1-4a, N1-3) (table 1)
Histologically/ cytologically proven resectable cervical lymph node metastases level III and/ or IV
Age ≥ 18
European Clinical Oncology Group (ECOG) performance status 0,1 or 2
Written informed consent
Exclusion Criteria:
Distant metastases
Esophageal carcinoma < 3 cm beneath UES
Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III)
Former radiotherapy or chemotherapy for esophageal carcinoma
Former radiotherapy precluding radiotherapy according the CROSS protocol
Inadequate pulmonary function disabling transthoracic resection
>10% loss of weight in the last six months
Previous neck dissection
New York heart association class III/IV and no history of active angina. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard V Hillegersberg, Prof Dr
Organizational Affiliation
UMCU
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases
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