Neoadjuvant Chemotherapy Versus Surgery Alone for Esophageal Squamous Cell Carcinoma

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395705
• Other study ID #: Henan CH
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: October 2022

Study information

• Verified date: October 2022
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasm
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• cisplatin and paclitaxel
Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.

Locations

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

Sponsors (6)

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

Country where clinical trial is conducted

China, 

Outcome

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