Status:
UNKNOWN
Paclitaxel, Cisplatin,5-FU vs. Radiotherapy Plus Paclitaxel, Cisplatin as Preoperative Therapy for Locally Advanced ESC
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsors:
Shanghai Chest Hospital
Henan Cancer Hospital
Conditions:
Esophageal Cancer Stage IIB
Esophageal Cancer Stage III
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
This is a Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophag...
Eligibility Criteria
Inclusion
- Histologically proven squamous cell carcinoma.
- All lesions are located in the thoracic esophagus.
- Clinical stages IIB and III (excluding T4) based on the 7th UICC-TNM classification.
- 20-75 years old.
- ECOG performance status of 0 or 1.
- Measurable lesions not required.
- No prior therapy against esophageal cancer except for complete resection by endoscopic mucosal resection/endoscopic submucosal dissection with either pM1/M2 disease or pM3 disease without vascular infiltration.
- No prior chemotherapy, radiotherapy or hormonal therapy against any cancers
- Adequate organ function.
- Written informed consent.
Exclusion
- Synchronous or metachronous double cancers, except for intramucosal tumor curatively resected by local therapy.
- Active infection requiring systemic therapy
- Positive hepatitis B surface antigen and hepatitis B core antigen or human immunodeficiency virus antibody.(only positive hepatitis B surface antigen should receive anti-virus treatment during study)
- Pregnant or lactating women or women of childbearing potential.
- Patients requiring systemic steroid medication.
- Iodine hypersensitivity.
- Psychiatric disease.
- Hypersensitivity for CremophorEL.
- Poorly controlled diabetes.
- Severe emphysema or pulmonary fibrosis.
- Poorly controlled hypertension.
- Unstable angina within 3 weeks or with a history of myocardial infarction within 6 months.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT03366883
Start Date
February 1 2018
End Date
December 31 2022
Last Update
January 9 2018
Active Locations (1)
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1
TianjinCIH
Tianjin, Tianjin Municipality, China, 300060