Status:
UNKNOWN
Study of Neo-adjuvant Chemoradiotherapy Followed by Minimally Invasive Esophagectomy for Squamous Cell Esophageal Cancer
Lead Sponsor:
Chengchu Zhu
Collaborating Sponsors:
Sun Yat-sen University
Fudan University
Conditions:
Squamous Cell Esophageal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The primary objective is to compare neo-adjuvant chemoradiotherapy followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE, pure radical chemoradiotherapy in terms of the overall...
Detailed Description
Esophageal cancer is one of the most difficult malignancies to cure. Surgical resection remains the primary treatment for localized esophageal cancer. It increases the chances of cure and alleviates t...
Eligibility Criteria
Inclusion
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable.
- Patients must not have received any prior anticancer therapy.
- More than 6 months of expected survival.
- Age ranges from 18 to 70 years.
- Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
- Karnofsky performance status (KPS) of 90 or more.
- Signed informed consent document on file.
Exclusion
- Patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine.
- Patients with concomitant hemorrhagic disease.
- Pregnant or breast feeding.
- Inability to use gastric conduit after esophagectomy because of a prior surgery.
- Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
- Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02188615
Start Date
June 1 2011
End Date
July 1 2019
Last Update
July 11 2014
Active Locations (1)
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1
Thaizhou Hospital
Linhai, Zhejiang, China, 317000