Phase 2
N=110
Esophagectomy in Treating Patients With High-Grade Dysplasia of the Esophagus or Stage I, Stage II, or Stage III Esophageal Cancer
Esophageal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00063986 ↗Enrolled (actual)
110
Serious AEs
71.4%
Results posted
Feb 2013
Primary outcome: Primary: Peri-operative Mortality at 30 Days — 0.029 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Minimally invasive esophagectomy (MIE) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Cooperative Oncology Group
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peri-operative Mortality at 30 Days |
0.029 | — |
| SECONDARY Rate of Conversion to Open Operation |
0.087 | — |
| SECONDARY Duration of Operating Time |
330 | — |
| SECONDARY Duration of Intensive Care Stay |
2 | — |
| SECONDARY Overall Length of Hospital Stay |
9 | — |
| SECONDARY Total Number of Lymph Nodes Dissected |
19 | — |
| SECONDARY 3-year Survival Rate |
0.584 | — |
| SECONDARY 30-day Peri-operative Mortality After Neoadjuvant Therapy |
0.057 | — |
| SECONDARY Rate of Conversion to Open Operation After Neoadjuvant Therapy |
0.086 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00063986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.