Status:
UNKNOWN
Phase III Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Affiliated Cancer Hospital of Shantou University Medical College
Shanghai Chest Hospital
Conditions:
Squamous Cell Esophageal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The primary objective is to compare neo-adjuvant chemoradiotherapy followed by surgery versus surgery, in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esopha...
Detailed Description
Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 480,000 new cases and 400,000 deaths occurred annually worldwide. In China, every year, no matter new cases or dea...
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 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT01216527
Start Date
June 1 2007
End Date
December 1 2019
Last Update
February 27 2017
Active Locations (2)
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1
Sun Yat-sen Uniersity Cancer Center
Guangzhou, Guangdong, China, 510060
2
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515000