Esophageal Cancer
Conditions
Keywords
esophageal cancer, minimally invasive esophagectomy (MIE)
Brief 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. 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.
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.
Interventions
PROCEDUREMinimally invasive esophagectomy (MIE)
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.
Sponsors
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 * 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.)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-operative Mortality at 30 Days | Assessed at 30 days from surgery | The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Operating Time | Assessed at surgery | The length of the operation (total of thoracic and abdominal components) is recorded. |
| Duration of Intensive Care Stay | Assessed after surgery until patients are out of intensive care | Number of post-operative days in intensive care is reported. |
| Overall Length of Hospital Stay | Assessed after surgery until patients are out of hospital | The number of days patients stayed in the hospital after surgery is reported. |
| Rate of Conversion to Open Operation | Assessed at surgery | Proportion of patients who required conversion to operation will be reported. |
| 3-year Survival Rate | Assessed at 3 years | Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death. |
| 30-day Peri-operative Mortality After Neoadjuvant Therapy | Assessed at 30 days after surgery | Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported. |
| Rate of Conversion to Open Operation After Neoadjuvant Therapy | Assessed at surgery | Proportion of patients with neoadjuvant therapy required conversion to open operation is reported. |
| Total Number of Lymph Nodes Dissected | Assessed at surgery | The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE. |
Countries
United States
Participant flow
Recruitment details
This study was activated on March 3, 2004, accrued its first patient on June 24, 2004, and closed on August 15, 2008. A total of 110 patients were accrued for this study.
Participants by arm
| Arm | Count |
|---|---|
| Minimally Invasive Esophagectomy (MIE) 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.
Only eligible and treated patients are included in the primary analysis. | 104 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible | 1 |
| Overall Study | Intra-operatively ineligible | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Minimally Invasive Esophagectomy (MIE) |
|---|---|
| Age, Continuous | 65 years |
| Region of Enrollment United States | 104 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 74 / 105 |
| serious Total, serious adverse events | 75 / 105 |
Outcome results
Primary
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.
Time frame: Assessed at 30 days from surgery
Population: Eligible and treated patients are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Minimally Invasive Esophagectomy (MIE) | Peri-operative Mortality at 30 Days | 0.029 proportion of participants |
Secondary
30-day Peri-operative Mortality After Neoadjuvant Therapy
Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.
Time frame: Assessed at 30 days after surgery
Population: 35 eligible and treated patients with neoadjuvant therapy are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Minimally Invasive Esophagectomy (MIE) | 30-day Peri-operative Mortality After Neoadjuvant Therapy | 0.057 Proportion of patients |
Secondary
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.
Time frame: Assessed at 3 years
Population: Eligible and treated patients are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Minimally Invasive Esophagectomy (MIE) | 3-year Survival Rate | 0.584 proportion of participants |
Secondary
Duration of Intensive Care Stay
Number of post-operative days in intensive care is reported.
Time frame: Assessed after surgery until patients are out of intensive care
Population: Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of intensive care stay is missing for 3 patients, so the results are based on data from 101 patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Minimally Invasive Esophagectomy (MIE) | Duration of Intensive Care Stay | 2 Days |
Secondary
Duration of Operating Time
The length of the operation (total of thoracic and abdominal components) is recorded.
Time frame: Assessed at surgery
Population: Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, 10 patients' length of operation data were unavailable, so the results are based on data from 94 patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Minimally Invasive Esophagectomy (MIE) | Duration of Operating Time | 330 Minutes |
Secondary
Overall Length of Hospital Stay
The number of days patients stayed in the hospital after surgery is reported.
Time frame: Assessed after surgery until patients are out of hospital
Population: Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of hospital stay is missing for 3 patients, so the results are based on data from 101 patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Minimally Invasive Esophagectomy (MIE) | Overall Length of Hospital Stay | 9 Days |
Secondary
Rate of Conversion to Open Operation
Proportion of patients who required conversion to operation will be reported.
Time frame: Assessed at surgery
Population: Eligible and treated patients are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Minimally Invasive Esophagectomy (MIE) | Rate of Conversion to Open Operation | 0.087 Proportion of patients |
Secondary
Rate of Conversion to Open Operation After Neoadjuvant Therapy
Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.
Time frame: Assessed at surgery
Population: 35 eligible and treated patients with neoadjuvant therapy are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Minimally Invasive Esophagectomy (MIE) | Rate of Conversion to Open Operation After Neoadjuvant Therapy | 0.086 Proportion of patients |
Secondary
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.
Time frame: Assessed at surgery
Population: Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, the number of lymph nodes removed is missing for 1 patient, so the results are based on data from 103 patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Minimally Invasive Esophagectomy (MIE) | Total Number of Lymph Nodes Dissected | 19 Lymph nodes |