Clinical trial NCT02395705: Neoadjuvant Chemotherapy Versus Surgery Alone for Esophageal Squamous Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Esophageal Neoplasm
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Tianjin Medical University Cancer Institute and Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Peking University Cancer Hospital & Institute
name: Hunan Province Tumor Hospital
name: Sun Yat-sen University
First posted: 2015-03-24
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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. Therefore, the optimal management of resectable esophageal squamous cell carcinomas differs widely among different areas based on local randomized controlled trials.

The neo-adjuvant chemotherapy might be a good strategy if sufficient local control is achieved by surgical treatment. This study defined the detail of surgery procedure and the region of lymphadenectomy and adopted cisplatin and paclitaxel as neoadjuvant chemotherapy regimens. We try to evaluate the efficacy and safety of this neo-adjuvant strategy.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival rate
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival rate
timeFrame: 1 years and 3 years
measure: Disease free survival
timeFrame: 5 years
measure: assessment in perioperation-Removal rate (R0 resection rate)
timeFrame: perioperative period
measure: assessment in perioperation-Rate of Operative Complication
timeFrame: perioperative period
measure: assessment in perioperation-Mortality of perioperation
timeFrame: perioperative period
measure: assessment in perioperation-Days of Hospitalization
timeFrame: perioperative period
measure: assessment in perioperation-Thoracic Drainage
timeFrame: perioperative period
measure: assessment in perioperation-Quantity of bleeding
timeFrame: perioperative period
measure: assessment in perioperation-Time of operation
timeFrame: perioperative period
measure: Quality of life
timeFrame: 1 years
measure: efficacy of neo-adjuvant chemotherapy--response rate
timeFrame: 1-4 days before operation
measure: toxicities of neo-adjuvant chemotherapy
timeFrame: from chemotherapy to perioperative period
measure: prognostic factors
timeFrame: 5 years
measure: predictive factors
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: FuZhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen Uniersity Cancer Center
state: Guangdong
city: Anyang
country: China
facility: Anyang cancer hospital
state: Henan
city: ZhengZhou
country: China
facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
state: Henan
city: Changsha
country: China
facility: Hunan Province Tumor Hospital
state: Hunan
city: Shanghai
country: China
facility: Fudan Universitay Shanghai Cancer Center
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
name: Yin Li, MD.&PhD.
role: PRINCIPAL_INVESTIGATOR
References: