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

E

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)

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)

Trial contacts and locations

41

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Data sourced from clinicaltrials.gov

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