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Esophageal CarcinomaPhase 3ROBOTNCT01544790

Robot-assisted Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy

A Phase 3 study testing Esophagectomy in people with Esophageal Carcinoma and Esophageal Cancer, run by UMC Utrecht at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is the first randomized controlled trial designed to compare robot-assisted minimally invasive thoraco-laparoscopic esophagectomy with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Carcinoma, Esophageal Cancer
What is being tested?
Esophagectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteNetherlands
Study dates
Apr 2012to Aug 2016
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
  • Surgical resectable (T1-4a, N0-3, M0)
  • Age ≥ 18 and ≤ 75 years
  • European Clinical Oncology Group (ECOG) performance status 0,1 or 2
  • Written informed consent

Who cannot join

  • Carcinoma of the cervical esophagus
  • Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III)
  • Prior thoracic surgery at the right hemithorax or thorax trauma (rationale: these patients will undergo open resection)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: Robot-assisted Minimally Invasive Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer. The ROBOT-trial: a Monocenter Randomized Controlled Trial.

This is the first randomized controlled trial designed to compare robot-assisted minimally invasive thoraco-laparoscopic esophagectomy with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer.

If our hypothesis is proved correct, robot-assisted minimally invasive thoraco-laparoscopic esophagectomy will result in a lower percentage of postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).

Read the detailed description

Rationale: As stated in the 2010 revised Dutch esophageal carcinoma guidelines, the golden standard for surgical treatment of esophageal carcinoma is open transthoracic esophagectomy. Recent evidence suggests that robot-assisted thoraco-laparoscopic esophagectomy using the Da Vinci ® robot can provide an extensive resection, with possibly better or at least equal radical (R0) resection rates and an equal number of dissected lymph nodes. This is accompanied with markedly reduced blood loss and reduction of overall complications with shorter intensive care unit (ICU) and hospital stay. Therefore, the robot-assisted thoraco-laparoscopic esophagectomy is now at a stage that it should be compared to the current standard of care in a randomized controlled trial.

Objective: Evaluate the benefits, risks and costs of robot-assisted thoraco-laparoscopic esophagectomy as an alternative to open transthoracic esophagectomy as treatment for esophageal cancer.

Study design: Randomized controlled parallel-group superiority trial Study population: Patients (age ≥ 18 and ≤ 75 jaar) with histologically proven surgically resectable (cT1-4a, N0-3, M0) squamous cell carcinoma, adenocarcinoma or undifferentiated esophageal carcinoma of the intrathoracic esophagus with European Clinical Oncology Group (ECOG) status 0, 1 or 2.

Intervention: 112 patients will be randomly allocated to either A) robot-assisted thoraco-laparoscopic esophagectomy (n=56) or B) open transthoracic esophagectomy (n=56).

Patients will receive the following interventions:

Group A. Robot-assisted thoraco-laparoscopic esophagectomy, with gastric conduit formation.

Group B. Open transthoracic esophagectomy, with gastric conduit formation.

Main study parameters/endpoints: Primary outcome is the percentage of overall complications (Grade 2 and higher) as stated by the modified Clavien-Dindo classification (MCDC).

Secondary outcomes are individual components of the primary endpoint (major and minor complications), (in hospital) mortality within 30 and 60 days, R0 resections, operation related events, postoperative recovery, oncologic outcomes, cost-effectiveness and quality of life.

Follow-up: 60 months after randomization

Being tested
Esophagectomy
Keywords
Esophageal carcinoma, Esophageal cancer, Robotic surgery, Esophagectomy, Minimally invasive
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsophagectomyProcedure or surgery

    Also called robot-assisted minimally invasive esophagectomy, robot-assisted thoraco-laparoscopic esophagectomy

    In this monocenter prospective randomized controlled trial, we compare robot-assisted minimally invasive esophagectomy with conventional open transthoracic esophagectomy.

Study groups in NCT01544790
Study groupRoleWhat they receive
Robot-assisted esophagectomyExperimentalRobot-assisted thoraco-laparoscopic esophagectomy with gastric conduit formation.
Receives: Procedure: Esophagectomy
Open transthoracic esophagectomyActive comparatortraditional open transthoracic esophagectomy with gastric conduit formation.
Receives: Procedure: Esophagectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative complications modified Clavien-Dindo classification (MCDC) grade 2 and higher

    The primary outcome of this study is the percentage of overall complications (Grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications (MCDC)

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary outcomes (8)

  1. Individual components of the primary endpoint (major and minor complications)

    Major complications (MCDC grade 2-4) Including: myocardial infarction, anastomotic leakage (clinical or radiologic diagnosis), anastomotic stenosis, chylothorax (chylous leakage, presence of chylous in chest tubes or indication start medium chain triglycerides containing tube feeding (Vivonex®), gastric tube necrosis (proven by gastroscopy), pulmonary embolus, deep vein thrombosis, vocal cord palsy or paralysis.

    Minor complications (MCDC grade 1) Including: wound infections, pleural effusions, delayed gastric emptying

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  2. (In hospital) Mortality within 30 and 60 days

    (In hospital) mortality and mortality within 30 and 60 days will be reported. The cause of death and the results of the autopsy report will be noted.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 60 days

  3. R0 resections (%)

    The pathological analysis will be finished within 2 weeks.

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  4. Operation related events

    Operation time is defined as time from incision until closure (minutes) for both the thoracic and the abdominal phase of the procedure. For the robotic procedure, set up time will be recorded separately. Unexpected events and complications occurring during the operation will be recorded (e.g. massive hemorrhage, perforation of other organs).

    Blood loss during operation (ml, per phase). In case of conversion to thoracotomy or laparotomy the reason for conversion has to be explained (absolute numbers/percentage).

    Measured: Day of surgery, up to 24 hours after surgery.

  5. Postoperative recovery

    Pain: Type and dose of used analgesics will be noted during the hospital admission period.

    Visual Analogue Scale (VAS) for pain will be noted at following times: pre-operatively and the first 10 days after surgery and a fixed periods during follow up (6 weeks, 6 months and yearly post-operatively up to 5 years).

    Length of intensive care unit (ICU) - medium care unit (MCU) stay (days). Length of hospital stay (days).

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  6. Oncologic outcomes

    2, 3 and 5 year disease free and overall survival

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months after surgery.

  7. Quality of life

    Questionnaires will be required at following times:

    SF-36, EORTC QLQ-C30 (Dutch), EORTC OES18 (Dutch) and EQ-5D (Appendix 1 \& 2) pre-operative < 5 days and 6 weeks, 6 months and yearly up to 5 years post-operatively.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months after surgery.

  8. Costs (euro)

    Direct general costs, due to extra operating room time and extra instruments. Indirect costs, such as reduced ICU or hospital stay.

    Measured: 5 years follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01544790
Sponsor's protocol ID
NL35048.041.11
Other IDs
11141
Acronym
ROBOT
Status last verified
Mar 2020
First submitted
17 Feb 2012
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • van der Sluis PC, van der Horst S, May AM, Schippers C, Brosens LAA, Joore HCA, Kroese CC, Haj Mohammad N, Mook S, Vleggaar FP, Borel Rinkes IHM, Ruurda JP, van Hillegersberg R. Robot-assisted Minimally Invasive Thoracolaparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer: A Randomized Controlled Trial. Ann Surg. 2019 Apr;269(4):621-630. doi: 10.1097/SLA.0000000000003031.

    PubMed 30308612

  • van der Sluis PC, Ruurda JP, van der Horst S, Verhage RJ, Besselink MG, Prins MJ, Haverkamp L, Schippers C, Rinkes IH, Joore HC, Ten Kate FJ, Koffijberg H, Kroese CC, van Leeuwen MS, Lolkema MP, Reerink O, Schipper ME, Steenhagen E, Vleggaar FP, Voest EE, Siersema PD, van Hillegersberg R. Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial). Trials. 2012 Nov 30;13:230. doi: 10.1186/1745-6215-13-230.

    PubMed 23199187

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Esophagectomy in people with Esophageal Carcinoma and Esophageal Cancer, 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 5 inclusion and 3 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 26 Mar 2020. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Postoperative complications modified Clavien-Dindo classification (MCDC) grade 2 and higher (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks). 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 NCT01544790, which also lists 2 linked publications.

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 26 Mar 2020.

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