Back to resultsNeoadjuvant Chemotherapy Versus Surgery Alone for Esophageal Squamous Cell Carcinoma
Primary Purpose
Esophageal Neoplasm
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
cisplatin and paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIA to IIIB, (7th Union for International Cancer Control, UICC-TNM).
- Patients must not have received any prior anticancer therapy of esophageal carcinoma.
- Age ranges from 18 to 75 years.
- Without operative contraindication.
- 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.
- 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).
- expected R0 resection.
- ECOG 0～2.
- Signed informed consent document on file. 10.No metastatic lymph node in cervical by color doppler sonography.
Exclusion Criteria:
- Multiple primary cancer.
- The subject cannot understand and sign the informed consent form(ICF).
- Patients with concomitant hemorrhagic disease.
- Any un expected reason for patients can't get operation.
- Inability to use gastric conduit after esophagectomy because of a prior surgery.
- Pregnant or breast feeding.
- Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.
Sites / Locations
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Beijing Cancer Hospital
- Fujian Medical University Union Hospital
- Sun Yat-sen Uniersity Cancer Center
- Anyang cancer hospital
- Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
- Hunan Province Tumor Hospital
- Fudan Universitay Shanghai Cancer Center
- Tianjin Medical University Cancer Institute and Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Neo-adjuvant chemotherapy group
Surgery alone group
Arm Description
Neo-adjuvant chemotherapy(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. Surgery: 2-3weeks after Neo-adjuvant chemotherapy Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).
Surgery: 2-3weeks after Neo-adjuvant chemotherapy Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).
Outcomes
Primary Outcome Measures
Overall survival rate
Secondary Outcome Measures
Overall survival rate
Disease free survival
assessment in perioperation-Removal rate (R0 resection rate)
The R0 resection rate of two groups
assessment in perioperation-Rate of Operative Complication
Complication rate after operation before discharge
assessment in perioperation-Mortality of perioperation
Mortality of perioperation 20 days before operation and 30 days after operation
assessment in perioperation-Days of Hospitalization
Days of Hospitalization after operation
assessment in perioperation-Thoracic Drainage
Thoracic Drainage days
assessment in perioperation-Quantity of bleeding
blood lose during operation
assessment in perioperation-Time of operation
the time from open thoracic cavity to the closure of the thoracic cavity
Quality of life
ECOG, KPS, NRS-2002, EORTC QLQ-ST018, EORTC QLQ-C30
efficacy of neo-adjuvant chemotherapy--response rate
Criteria:Response Evaluation Criteria in Solid Tumors，RECIST. Pathologic Complete Response Rate. Pathologic Response Rate.
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
prognostic factors
prognostic factors for overall survival of both groups
predictive factors
predictive factors for the efficiency of neo-adjuvant chemotherapy
Full Information
NCT ID
NCT02395705
First Posted
February 26, 2015
Last Updated
October 3, 2022
Sponsor
Henan Cancer Hospital
Collaborators
Tianjin Medical University Cancer Institute and Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University Cancer Hospital & Institute, Hunan Province Tumor Hospital, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02395705
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
October 2022 (Actual)
Study Completion Date
October 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital
Collaborators
Tianjin Medical University Cancer Institute and Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University Cancer Hospital & Institute, Hunan Province Tumor Hospital, Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
528 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neo-adjuvant chemotherapy group
Arm Type
Experimental
Arm Description
Neo-adjuvant chemotherapy(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.
Surgery:
2-3weeks after Neo-adjuvant chemotherapy
Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality.
Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).
Arm Title
Surgery alone group
Arm Type
No Intervention
Arm Description
Surgery:
2-3weeks after Neo-adjuvant chemotherapy
Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality.
Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).
Intervention Type
Drug
Intervention Name(s)
cisplatin and paclitaxel
Other Intervention Name(s)
TP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival rate
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival rate
Time Frame
1 years and 3 years
Title
Disease free survival
Time Frame
5 years
Title
assessment in perioperation-Removal rate (R0 resection rate)
Description
The R0 resection rate of two groups
Time Frame
perioperative period
Title
assessment in perioperation-Rate of Operative Complication
Description
Complication rate after operation before discharge
Time Frame
perioperative period
Title
assessment in perioperation-Mortality of perioperation
Description
Mortality of perioperation 20 days before operation and 30 days after operation
Time Frame
perioperative period
Title
assessment in perioperation-Days of Hospitalization
Description
Days of Hospitalization after operation
Time Frame
perioperative period
Title
assessment in perioperation-Thoracic Drainage
Description
Thoracic Drainage days
Time Frame
perioperative period
Title
assessment in perioperation-Quantity of bleeding
Description
blood lose during operation
Time Frame
perioperative period
Title
assessment in perioperation-Time of operation
Description
the time from open thoracic cavity to the closure of the thoracic cavity
Time Frame
perioperative period
Title
Quality of life
Description
ECOG, KPS, NRS-2002, EORTC QLQ-ST018, EORTC QLQ-C30
Time Frame
1 years
Title
efficacy of neo-adjuvant chemotherapy--response rate
Description
Criteria:Response Evaluation Criteria in Solid Tumors，RECIST. Pathologic Complete Response Rate. Pathologic Response Rate.
Time Frame
1-4 days before operation
Title
toxicities of neo-adjuvant chemotherapy
Description
According to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0). The complete rate of protocol
Time Frame
from chemotherapy to perioperative period
Title
prognostic factors
Description
prognostic factors for overall survival of both groups
Time Frame
5 years
Title
predictive factors
Description
predictive factors for the efficiency of neo-adjuvant chemotherapy
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIA to IIIB, (7th Union for International Cancer Control, UICC-TNM).
Patients must not have received any prior anticancer therapy of esophageal carcinoma.
Age ranges from 18 to 75 years.
Without operative contraindication.
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.
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).
expected R0 resection.
ECOG 0～2.
Signed informed consent document on file. 10.No metastatic lymph node in cervical by color doppler sonography.
Exclusion Criteria:
Multiple primary cancer.
The subject cannot understand and sign the informed consent form(ICF).
Patients with concomitant hemorrhagic disease.
Any un expected reason for patients can't get operation.
Inability to use gastric conduit after esophagectomy because of a prior surgery.
Pregnant or breast feeding.
Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin Li, MD.&PhD.
Organizational Affiliation
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Fujian Medical University Union Hospital
City
FuZhou
State/Province
Fujian
Country
China
Facility Name
Sun Yat-sen Uniersity Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Anyang cancer hospital
City
Anyang
State/Province
Henan
Country
China
Facility Name
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
City
ZhengZhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Hunan Province Tumor Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Fudan Universitay Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Chemotherapy Versus Surgery Alone for Esophageal Squamous Cell Carcinoma
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