## Protocol Section
### Identification Module
**NCT ID:** NCT02426879

**Acronym:** Node

**Brief Title:** Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases

**Official Title:** Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study

#### Organization Study ID Info
**ID:** NL48231.041.14
#### Organization
**Class:** OTHER
**Full Name:** UMC Utrecht
### Status Module
#### Completion Date
**Date:** 2021-01-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-09-30

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-01-25

**Type:** ACTUAL

#### Start Date
**Date:** 2015-02-11

**Type:** ACTUAL

**Status Verified Date:** 2021-09

#### Study First Post Date
**Date:** 2015-04-27
**Type:** ESTIMATED
**Study First Submit Date:** 2015-01-30
**Study First Submit QC Date:** 2015-04-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** UMC Utrecht

#### Responsible Party

**Investigator Affiliation:** UMC Utrecht

**Investigator Full Name:** Richard van Hillegersberg

**Investigator Title:** prof Dr

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Cancer

- Squamous Cell Carcinoma

- Adenocarcinoma

- Malignancy

**Keywords:**

- three-field lymphadenectomy

- cervical metastases

- esophagectomy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** esophagectomy with three-field lymphnode dissection

**Intervention Names:**

- Procedure: esophagectomy with three-field lymphnode dissection

**Label:** surgery

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- surgery

**Description:** robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection

**Name:** esophagectomy with three-field lymphnode dissection

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** pTNM stage

**Measure:** pathology results 1

**Time Frame:** 5 years

**Description:** site of tumour

**Measure:** pathology results 2

**Time Frame:** 5 years

**Description:** length of tumour

**Measure:** pathology results 3

**Time Frame:** 5 years

**Description:** type of tumour

**Measure:** pathology results 4

**Time Frame:** 5 years

**Description:** gradation of tumour

**Measure:** pathology results 5

**Time Frame:** 5 years

**Description:** margins of resection (R0, R1, R2)

**Measure:** pathology results 6

**Time Frame:** 5 years

**Description:** mandard score

**Measure:** pathology results 7

**Time Frame:** 5 years

**Description:** lymphnode status

**Measure:** pathology results 8

**Time Frame:** 5 years

**Description:** vaso-invasion

**Measure:** pathology results 9

**Time Frame:** 5 years

**Description:** perineural growth

**Measure:** pathology results 10

**Time Frame:** 5 years

#### Primary Outcomes

**Description:** Safety is measured by the percentage of overall postoperative complications grade 3b and higher as stated by the modified Clavien-Dindo classification (MCDC)

**Measure:** 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

#### Secondary Outcomes

**Description:** in-hospital mortality and 30- and 60 day mortality (absolute numbers/ percentages)

**Measure:** mortality

**Time Frame:** 5 years

**Description:** 5 year overall- and disease free survival.

**Measure:** survival

**Time Frame:** 5 years

**Description:** QoL is measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)

**Measure:** quality of life measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)

**Time Frame:** 10 years

**Description:** duration of surgery (minutes)

**Measure:** operation related events 1

**Time Frame:** 5 years

**Description:** reason for prolongation of surgery if applicable

**Measure:** operation related events 2

**Time Frame:** 5 years

**Description:** unexpected events/ complications

**Measure:** operation related events 3

**Time Frame:** 5 years

**Description:** bloodloss (ml) reason for conversion if applicable.

**Measure:** operation related events 4

**Time Frame:** 5 years

**Description:** reason for conversion if applicable.

**Measure:** operation related events 5

**Time Frame:** 5 years

**Description:** duration of intubation (days), length of ICU/ MCU stay(days), length of hospital stay (days),

**Measure:** postoperative recovery

**Time Frame:** 5 years

### Eligibility Module

**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

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Utrecht

**Country:** Netherlands

**Facility:** UMC Utrecht

**Zip:** 3584 CX

#### Overall Officials

**Official 1:**

**Affiliation:** UMCU

**Name:** Richard V Hillegersberg, Prof Dr

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M8088

- Name: Esophageal Neoplasms

- Relevance: HIGH

- As Found: Esophageal Cancer

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastases

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11204

- Name: Lymphatic Metastasis

- Relevance: HIGH

- As Found: Lymph Node Metastasis

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2141

- Name: Esophageal Cancer

- Relevance: HIGH

- As Found: Esophageal Cancer

### Condition Browse Module - Meshes

- ID: D000009362

- Term: Neoplasm Metastasis

- ID: D000004938

- Term: Esophageal Neoplasms

- ID: D000008207

- Term: Lymphatic Metastasis

### Misc Info Module

- Version Holder: 2024-05-24
