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Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial


Open Versus Laparoscopically-assisted Esophagectomy for Cancer


Inclusion Criteria:



- Squamous cell or adenocarcinoma of the thoracic esophagus T1, T2, T3, N0-N1, M0

- Middle or lower third esophageal carcinoma, junctional tumor Siewert type I

- Patients who underwent or not neoadjuvant chemotherapy or chemoradiation

- Tumor deemed to be resectable in a curative intent at the preoperative setting

- Age less than 75 years old, OMS status 0, 1 or 2

- Patient who can undergo one or the other surgical modality

- Written informed consent form

- Possible follow-up

Exclusion Criteria:

- Presence of detectable visceral metastases or peritoneal carcinomatosis

- Another malignant tumor within the last 5 years (not including basal cell skin
carcinoma or cancer of the cervix)

- Weight loss exceeding 15%

- Any other simultaneous experimental treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm.

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Christophe Mariette, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Lille, France

Authority:

France: National Consultative Ethics Committee for Health and Life Sciences

Study ID:

2009-A00144-53

NCT ID:

NCT00937456

Start Date:

October 2009

Completion Date:

October 2014

Related Keywords:

  • Esophageal Cancer
  • Esophagus
  • Cancer
  • Surgery
  • Laparoscopy
  • Randomized trial
  • Esophageal cancer deemed to be resectable
  • Esophageal Diseases
  • Esophageal Neoplasms

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