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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426879
Recruitment Status : Recruiting
First Posted : April 27, 2015
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Richard van Hillegersberg, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE April 27, 2015
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE February 11, 2015
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2015)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2015)
  • mortality [ Time Frame: 5 years ]
    in-hospital mortality and 30- and 60 day mortality (absolute numbers/ percentages)
  • survival [ Time Frame: 5 years ]
    5 year overall- and disease free survival.
  • 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)
  • operation related events 1 [ Time Frame: 5 years ]
    duration of surgery (minutes)
  • operation related events 2 [ Time Frame: 5 years ]
    reason for prolongation of surgery if applicable
  • operation related events 3 [ Time Frame: 5 years ]
    unexpected events/ complications
  • operation related events 4 [ Time Frame: 5 years ]
    bloodloss (ml) reason for conversion if applicable.
  • operation related events 5 [ Time Frame: 5 years ]
    reason for conversion if applicable.
  • postoperative recovery [ Time Frame: 5 years ]
    duration of intubation (days), length of ICU/ MCU stay(days), length of hospital stay (days),
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 21, 2015)
  • pathology results 1 [ Time Frame: 5 years ]
    pTNM stage
  • pathology results 2 [ Time Frame: 5 years ]
    site of tumour
  • pathology results 3 [ Time Frame: 5 years ]
    length of tumour
  • pathology results 4 [ Time Frame: 5 years ]
    type of tumour
  • pathology results 5 [ Time Frame: 5 years ]
    gradation of tumour
  • pathology results 6 [ Time Frame: 5 years ]
    margins of resection (R0, R1, R2)
  • pathology results 7 [ Time Frame: 5 years ]
    mandard score
  • pathology results 8 [ Time Frame: 5 years ]
    lymphnode status
  • pathology results 9 [ Time Frame: 5 years ]
    vaso-invasion
  • pathology results 10 [ Time Frame: 5 years ]
    perineural growth
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases
Official Title  ICMJE Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Squamous Cell Carcinoma
  • Adenocarcinoma
  • Malignancy
Intervention  ICMJE Procedure: esophagectomy with three-field lymphnode dissection
robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection
Study Arms  ICMJE surgery
esophagectomy with three-field lymphnode dissection
Intervention: Procedure: esophagectomy with three-field lymphnode dissection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2027
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sylvia van der Horst, Drs 088-7558074 shorst2@umcutrecht.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02426879
Other Study ID Numbers  ICMJE NL48231.041.14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard van Hillegersberg, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard V Hillegersberg, Prof Dr UMCU
PRS Account UMC Utrecht
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP