Esophageal Neoplasm Clinical Trial
Official title:
A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemotherapy Paclitaxel + Cisplatin Versus Surgery Alone for Stage IIA-IIIB Esophageal Squamous Cell Carcinoma
NCT number | NCT02395705 |
Other study ID # | Henan CH |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | October 2022 |
Verified date | October 2022 |
Source | Henan Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients.
Status | Completed |
Enrollment | 528 |
Est. completion date | October 2022 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIA to IIIB, (7th Union for International Cancer Control, UICC-TNM). 2. Patients must not have received any prior anticancer therapy of esophageal carcinoma. 3. Age ranges from 18 to 75 years. 4. Without operative contraindication. 5. 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, total bilirubin(TBIL)=1.5N, aspartate aminotransferase (AST)=2.5N, alanine aminotransferase(ALT)=2.5N, prothrombin time(PT)=1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)=1.5N. 6. Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS). 7. expected R0 resection. 8. ECOG 0~2. 9. Signed informed consent document on file. 10.No metastatic lymph node in cervical by color doppler sonography. Exclusion Criteria: 1. Multiple primary cancer. 2. The subject cannot understand and sign the informed consent form(ICF). 3. Patients with concomitant hemorrhagic disease. 4. Any un expected reason for patients can't get operation. 5. Inability to use gastric conduit after esophagectomy because of a prior surgery. 6. Pregnant or breast feeding. 7. Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel. |
Country | Name | City | State |
---|---|---|---|
China | Anyang cancer hospital | Anyang | Henan |
China | Beijing Cancer Hospital | Beijing | Beijing |
China | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing |
China | Hunan Province Tumor Hospital | Changsha | Hunan |
China | Fujian Medical University Union Hospital | FuZhou | Fujian |
China | Sun Yat-sen Uniersity Cancer Center | Guangzhou | Guangdong |
China | Fudan Universitay Shanghai Cancer Center | Shanghai | Shanghai |
China | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin |
China | Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university | ZhengZhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan Cancer Hospital | Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Hunan Province Tumor Hospital, Peking University Cancer Hospital & Institute, Sun Yat-sen University, Tianjin Medical University Cancer Institute and Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival rate | 5 years | ||
Secondary | Overall survival rate | 1 years and 3 years | ||
Secondary | Disease free survival | 5 years | ||
Secondary | assessment in perioperation-Removal rate (R0 resection rate) | The R0 resection rate of two groups | perioperative period | |
Secondary | assessment in perioperation-Rate of Operative Complication | Complication rate after operation before discharge | perioperative period | |
Secondary | assessment in perioperation-Mortality of perioperation | Mortality of perioperation 20 days before operation and 30 days after operation | perioperative period | |
Secondary | assessment in perioperation-Days of Hospitalization | Days of Hospitalization after operation | perioperative period | |
Secondary | assessment in perioperation-Thoracic Drainage | Thoracic Drainage days | perioperative period | |
Secondary | assessment in perioperation-Quantity of bleeding | blood lose during operation | perioperative period | |
Secondary | assessment in perioperation-Time of operation | the time from open thoracic cavity to the closure of the thoracic cavity | perioperative period | |
Secondary | Quality of life | ECOG, KPS, NRS-2002, EORTC QLQ-ST018, EORTC QLQ-C30 | 1 years | |
Secondary | efficacy of neo-adjuvant chemotherapy--response rate | Criteria:Response Evaluation Criteria in Solid Tumors,RECIST. Pathologic Complete Response Rate. Pathologic Response Rate. | 1-4 days before operation | |
Secondary | toxicities of neo-adjuvant chemotherapy | According to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0). The complete rate of protocol | from chemotherapy to perioperative period | |
Secondary | prognostic factors | prognostic factors for overall survival of both groups | 5 years | |
Secondary | predictive factors | predictive factors for the efficiency of neo-adjuvant chemotherapy | 2 years |
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