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

Eastern Cooperative Oncology Group

Status and phase: Completed; Phase 2

Conditions: Esophageal Cancer

Treatments: Procedure: Minimally invasive esophagectomy (MIE)

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00063986

CDR0000305866

E2202 (Other Identifier)

U10CA021115 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Minimally invasive esophagectomy (MIE)

Experimental group

Description:

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.

Treatment:

Procedure: Minimally invasive esophagectomy (MIE)