Neoadjuvant Chemotherapy Versus Surgery Alone for Esophageal Squamous Cell Carcinoma
NCT ID: NCT02395705
Last Updated: 2022-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
528 participants
INTERVENTIONAL
2015-06-30
2022-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neo-adjuvant chemotherapy group
Neo-adjuvant chemotherapy(cisplatin and paclitaxel):
1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.
Surgery:
2-3weeks after Neo-adjuvant chemotherapy
1. Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality.
2. 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).
cisplatin and paclitaxel
1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.
Surgery alone group
Surgery:
2-3weeks after Neo-adjuvant chemotherapy
1. Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality.
2. 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).
No interventions assigned to this group
Interventions
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cisplatin and paclitaxel
1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Peking University Cancer Hospital & Institute
OTHER
Hunan Province Tumor Hospital
OTHER
Sun Yat-sen University
OTHER
Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Yin Li
Vice-President, Director of thoracic surgery department, Henan Cancer Hospital
Principal Investigators
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Yin Li, MD.&PhD.
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yat-sen Uniersity Cancer Center
Guangzhou, Guangdong, China
Anyang cancer hospital
Anyang, Henan, China
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China
Hunan Province Tumor Hospital
Changsha, Hunan, China
Fudan Universitay Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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Henan CH
Identifier Type: -
Identifier Source: org_study_id
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