CancerNodeNCT02426879
Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases
A study testing esophagectomy with three-field lymphnode dissection in people with Cancer and Squamous Cell Carcinoma, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer, Squamous Cell Carcinoma, Adenocarcinoma
- What is being tested?
- esophagectomy with three-field lymphnode dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Feb 2015to 25 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- >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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study
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.
Read the 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
- Cancer, Squamous Cell Carcinoma, Adenocarcinoma, Malignancy
- Being tested
- esophagectomy with three-field lymphnode dissection
- Keywords
- three-field lymphadenectomy, cervical metastases, esophagectomy
- Medical subject headings
- Neoplasms, Carcinoma, Squamous Cell, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagectomy with three-field lymphnode dissectionProcedure or surgery
robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection
| Study group | Role | What they receive |
|---|---|---|
| surgery | Other | esophagectomy with three-field lymphnode dissection Receives: Procedure: esophagectomy with three-field lymphnode dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 years
Secondary outcomes (9)
mortality
in-hospital mortality and 30- and 60 day mortality (absolute numbers/ percentages)
Measured: 5 years
survival
5 year overall- and disease free survival.
Measured: 5 years
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)
Measured: 10 years
operation related events 1
duration of surgery (minutes)
Measured: 5 years
operation related events 2
reason for prolongation of surgery if applicable
Measured: 5 years
operation related events 3
unexpected events/ complications
Measured: 5 years
operation related events 4
bloodloss (ml) reason for conversion if applicable.
Measured: 5 years
operation related events 5
reason for conversion if applicable.
Measured: 5 years
postoperative recovery
duration of intubation (days), length of ICU/ MCU stay(days), length of hospital stay (days),
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study start11 Feb 2015
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard van Hillegersberg, UMC Utrecht
- Investigators
- Richard V Hillegersberg, Prof Dr, Principal investigator, UMCU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426879
- Sponsor's protocol ID
- NL48231.041.14
- Acronym
- Node
- Status last verified
- Sep 2021
- First submitted
- 30 Jan 2015
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Horst S, Weijs TJ, Braunius WW, Mook S, Mohammed NH, Brosens L, van Rossum PSN, Weusten BLAM, Ruurda JP, van Hillegersberg R. Safety and Feasibility of Robot-Assisted Minimally Invasive Esophagectomy (RAMIE) with Three-Field Lymphadenectomy and Neoadjuvant Chemoradiotherapy in Patients with Resectable Esophageal Cancer and Cervical Lymph Node Metastasis. Ann Surg Oncol. 2023 May;30(5):2743-2752. doi: 10.1245/s10434-022-12996-x. Epub 2023 Jan 27.
PubMed 36707482
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases Node Study
- ClinicalTrials.gov ID
- NCT02426879
- Acronym / sponsor ID
- Node / NL48231.041.14
- Conditions
- Cancer, Squamous Cell Carcinoma, Adenocarcinoma, Malignancy
- Keywords
- three-field lymphadenectomy, cervical metastases, esophagectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 11 Feb 2015 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery | Other | Procedure: esophagectomy with three-field lymphnode dissectionesophagectomy with three-field lymphnode dissection |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esophagectomy with three-field lymphnode dissectionrobot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection | Procedure or surgery | surgery |
Primary outcome
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)
9 secondary outcomes
mortality
Time frame: 5 years
survival
Time frame: 5 years
quality of life measured by questionnaires (EORTC-QLQ_C30 and EORTC-QLQ_Oes18)
Time frame: 10 years
operation related events 1
Time frame: 5 years
operation related events 2
Time frame: 5 years
operation related events 3
Time frame: 5 years
operation related events 4
Time frame: 5 years
operation related events 5
Time frame: 5 years
postoperative recovery
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Derived from this study: PubMed 36707482van der Horst S, Weijs TJ, Braunius WW, Mook S, Mohammed NH, Brosens L, van Rossum PSN, Weusten BLAM, Ruurda JP, van Hillegersberg R. Safety and Feasibility of Robot-Assisted Minimally Invasive Esophagectomy (RAMIE) with Three-Field Lymphadenectomy and Neoadjuvant Chemoradiotherapy in Patients with Resectable Esophageal Cancer and Cervical Lymph Node Metastasis. Ann Surg Oncol. 2023 May;30(5):2743-2752. doi: 10.1245/s10434-022-12996-x. Epub 2023 Jan 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard V Hillegersberg, Prof Dr principal investigator
UMCU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esophagectomy with three-field lymphnode dissection in people with Cancer and Squamous Cell Carcinoma, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02426879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.