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NCT Number: NCT02426879

Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases

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.

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Key information

Conditions

Cancer Adenocarcinoma Carcinoma Carcinoma, Squamous Cell Malignancy Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

esophagectomy with three-field lymphnode dissection

Procedure

robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study

Acronym: Node

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2015
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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