Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases

Cancer Clinical Trial

— Node  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426879
• Other study ID #: NL48231.041.14
• Status: Completed
• Phase: N/A
• Start date: February 11, 2015
• Est. completion date: January 25, 2021

Study information

• Verified date: September 2021
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 25, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Cancer
• Esophageal Neoplasms
• Lymphatic Metastasis
• Malignancy
• Neoplasm Metastasis
• Squamous Cell Carcinoma

Intervention

Procedure:
• esophagectomy with three-field lymphnode dissection
robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pathology results 1	pTNM stage	5 years
Other	pathology results 2	site of tumour	5 years
Other	pathology results 3	length of tumour	5 years
Other	pathology results 4	type of tumour	5 years
Other	pathology results 5	gradation of tumour	5 years
Other	pathology results 6	margins of resection (R0, R1, R2)	5 years
Other	pathology results 7	mandard score	5 years
Other	pathology results 8	lymphnode status	5 years
Other	pathology results 9	vaso-invasion	5 years
Other	pathology results 10	perineural growth	5 years
Primary	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)	5 years
Secondary	mortality	in-hospital mortality and 30- and 60 day mortality (absolute numbers/ percentages)	5 years
Secondary	survival	5 year overall- and disease free survival.	5 years
Secondary	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)	10 years
Secondary	operation related events 1	duration of surgery (minutes)	5 years
Secondary	operation related events 2	reason for prolongation of surgery if applicable	5 years
Secondary	operation related events 3	unexpected events/ complications	5 years
Secondary	operation related events 4	bloodloss (ml) reason for conversion if applicable.	5 years
Secondary	operation related events 5	reason for conversion if applicable.	5 years
Secondary	postoperative recovery	duration of intubation (days), length of ICU/ MCU stay(days), length of hospital stay (days),	5 years