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Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases (Node)

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ClinicalTrials.gov Identifier: NCT02426879
Recruitment Status : Recruiting
First Posted : April 27, 2015
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Richard van Hillegersberg, UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Cancer Squamous Cell Carcinoma Adenocarcinoma Malignancy Procedure: esophagectomy with three-field lymphnode dissection Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study
Actual Study Start Date : February 11, 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
surgery
esophagectomy with three-field lymphnode dissection
Procedure: esophagectomy with three-field lymphnode dissection
robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection




Primary Outcome Measures :
  1. Safety 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 ]
    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 :
  1. mortality [ Time Frame: 5 years ]
    in-hospital mortality and 30- and 60 day mortality (absolute numbers/ percentages)

  2. survival [ Time Frame: 5 years ]
    5 year overall- and disease free survival.

  3. quality of life measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18) [ Time Frame: 10 years ]
    QoL is measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)

  4. operation related events 1 [ Time Frame: 5 years ]
    duration of surgery (minutes)

  5. operation related events 2 [ Time Frame: 5 years ]
    reason for prolongation of surgery if applicable

  6. operation related events 3 [ Time Frame: 5 years ]
    unexpected events/ complications

  7. operation related events 4 [ Time Frame: 5 years ]
    bloodloss (ml) reason for conversion if applicable.

  8. operation related events 5 [ Time Frame: 5 years ]
    reason for conversion if applicable.

  9. postoperative recovery [ Time Frame: 5 years ]
    duration of intubation (days), length of ICU/ MCU stay(days), length of hospital stay (days),


Other Outcome Measures:
  1. pathology results 1 [ Time Frame: 5 years ]
    pTNM stage

  2. pathology results 2 [ Time Frame: 5 years ]
    site of tumour

  3. pathology results 3 [ Time Frame: 5 years ]
    length of tumour

  4. pathology results 4 [ Time Frame: 5 years ]
    type of tumour

  5. pathology results 5 [ Time Frame: 5 years ]
    gradation of tumour

  6. pathology results 6 [ Time Frame: 5 years ]
    margins of resection (R0, R1, R2)

  7. pathology results 7 [ Time Frame: 5 years ]
    mandard score

  8. pathology results 8 [ Time Frame: 5 years ]
    lymphnode status

  9. pathology results 9 [ Time Frame: 5 years ]
    vaso-invasion

  10. pathology results 10 [ Time Frame: 5 years ]
    perineural growth



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426879


Contacts
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Contact: Sylvia van der Horst, Drs 088-7558074 shorst2@umcutrecht.nl

Locations
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Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Richard van Hillegersberg, Propf Dr    +3188-7558074    r.vanhillegersberg@umcutrecht.nl   
Contact: Sylvia van der Horst, Drs    +3188-7558074    shorst2@umcutrecht.nl   
Principal Investigator: Richard van Hillegersberg, MD, PhD         
Sub-Investigator: Jelle P. Ruurda, MD, PhD         
Sub-Investigator: sylvia van der Horst, Drs         
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: Richard V Hillegersberg, Prof Dr UMCU

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Responsible Party: Richard van Hillegersberg, prof Dr, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02426879     History of Changes
Other Study ID Numbers: NL48231.041.14
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Keywords provided by Richard van Hillegersberg, UMC Utrecht:
three-field lymphadenectomy
cervical metastases
esophagectomy
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasm Metastasis
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases