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Esophageal CancerPhase 2NCT00063986

Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer

A Phase 2 study testing Minimally invasive esophagectomy (MIE) in people with Esophageal Cancer, run by Eastern Cooperative Oncology Group at 41 sites in United States.

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

RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
Minimally invasive esophagectomy (MIE)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
41 sitesUnited States
Study dates
24 Jun 2004to Aug 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • DISEASE CHARACTERISTICS:
  • High grade dysplasia of the esophagus who would undergo esophagectomy OR esophageal cancer at stage T1-T3, N0-N1 who require esophagectomy (patients with M1 disease and/or bulky lymph node involvement were excluded).
  • Pathological confirmation of a diagnosis of cancer or high-grade dysplasia of the esophagus by biopsy.
  • Computerized tomography (CT) scan of chest and abdomen within 6 weeks prior to registration
  • Stomach must be available for conduit
  • Age of 18 and over
Show all 12Show fewer
  • ECOG performance status of 0-2
  • Creatinine less than 2 mg/dL
  • Patients with esophageal cancer who would be treated with neoadjuvant chemotherapy and/or radiation were eligible. If patients were registered prior to receiving neoadjuvant chemotherapy they were allowed up to 5 months to complete therapy and any restaging that was necessary before operation was performed.
  • The patient was considered an appropriate candidate for surgery based on preoperative clinical staging and physiological factors prior to registration as documented in the surgical plan. Pre-operative staging should include:
  • Endoscopic ultrasound (EUS)
  • Positron emission tomography (PET) scan and/or laparoscopic staging (Laparoscopic staging could be performed on the day of resection. Additional evaluation was recommended if the PET scan suggested distant metastatic disease.)

Who cannot join

  • Cancer extending into the stomach more than 20%
  • Prior anti-reflux or gastric operations
  • Prior right thoracotomy
  • Prior major neck operation other than the removal of superficial skin lesion

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota, 55455

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131-2197

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • HealthEast Cancer Care at St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota, 55379

  • Mercy Medical Center

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • HealthEast Cancer Care at Woodwinds Health Campus

    Woodbury, Minnesota, 55125

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study

RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery.

PURPOSE: This phase II trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage I, stage II, or stage III esophageal cancer.

Read the detailed description

OBJECTIVES:

  • Determine the feasibility of performing minimally invasive esophagectomy (MIE), in terms of 30-day mortality, in patients with high-grade dysplasia of the esophagus or stage I-III esophageal cancer.
  • Determine the complications associated with this procedure in these patients.
  • Determine the rate at which conversion to open operation is required in patients undergoing this procedure.
  • Determine the length of the operation, duration of intensive care unit stay, and length of hospital stay in patients undergoing this procedure.
  • Determine feasibility and conversion rate of MIE after neoadjuvant therapy.
  • Assess the effectiveness of lymph node dissection by MIE by recording the total number of lymph nodes dissected.
  • Assess outcomes at follow-up to three years.

OUTLINE: This is a multicenter study.

Patients undergo minimally invasive esophagectomy comprising video-assisted thoracoscopy to mobilize the thoracic esophagus in combination with laparoscopy to complete the esophagectomy and a neck incision to mobilize the cervical esophagus. Mortality at 30 days is assessed.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

ACTUAL ACCRUAL: A total of 110 patients were accrued for this study.

Being tested
Minimally invasive esophagectomy (MIE)
Keywords
esophageal cancer, minimally invasive esophagectomy (MIE)
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Minimally invasive esophagectomy (MIE)Procedure or surgery

    Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.

Study groups in NCT00063986
Study groupRoleWhat they receive
Minimally invasive esophagectomy (MIE)ExperimentalWithin 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
Receives: Procedure: Minimally invasive esophagectomy (MIE)

What is being measured

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

  1. Peri-operative Mortality at 30 Days

    The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.

    Measured: Assessed at 30 days from surgery

Secondary outcomes (8)

  1. Rate of Conversion to Open Operation

    Proportion of patients who required conversion to operation will be reported.

    Measured: Assessed at surgery

  2. Duration of Operating Time

    The length of the operation (total of thoracic and abdominal components) is recorded.

    Measured: Assessed at surgery

  3. Duration of Intensive Care Stay

    Number of post-operative days in intensive care is reported.

    Measured: Assessed after surgery until patients are out of intensive care

  4. Overall Length of Hospital Stay

    The number of days patients stayed in the hospital after surgery is reported.

    Measured: Assessed after surgery until patients are out of hospital

  5. Total Number of Lymph Nodes Dissected

    The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.

    Measured: Assessed at surgery

  6. 3-year Survival Rate

    Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.

    Measured: Assessed at 3 years

  7. 30-day Peri-operative Mortality After Neoadjuvant Therapy

    Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.

    Measured: Assessed at 30 days after surgery

  8. Rate of Conversion to Open Operation After Neoadjuvant Therapy

    Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.

    Measured: Assessed at surgery

Timeline

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

  1. First posted9 Jul 2003 (estimated)
  2. Study start24 Jun 2004
  3. Primary completionDec 2010
  4. Study completionAug 2012

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00063986
Sponsor's protocol ID
CDR0000305866
Other IDs
U10CA021115, E2202
Status last verified
Jun 2023
First submitted
8 Jul 2003
Last updated
29 Jun 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Minimally invasive esophagectomy (MIE) in people with Esophageal Cancer, run by Eastern Cooperative Oncology Group at 41 sites in United States.

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 12 inclusion and 4 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Peri-operative Mortality at 30 Days (time frame: Assessed at 30 days from surgery). 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 NCT00063986.

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 29 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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