| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Squamous Cell Carcinoma | Drug: Nab-paclitaxel and Cisplatin Procedure: surgery | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 202 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Effectiveness and Safety of Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin Followed by Surgery Versus Surgery Alone for Locally Advanced Esophageal Squamous Cell Carcinoma |
| Actual Study Start Date : | April 24, 2019 |
| Estimated Primary Completion Date : | June 24, 2026 |
| Estimated Study Completion Date : | December 24, 2026 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Neo-adjuvant chemotherapy group
cisplatin and nab-paclitaxel: Nab-paclitaxel, 125mg/m(2), d1,d8, Cisplatin, 75mg/m(2), d1, 3 week, 2 cycles. Surgery: 4-6weeks after Neo-adjuvant chemotherapy |
Drug: Nab-paclitaxel and Cisplatin
Nab-paclitaxel,125mg/m(2), d1,d8, Cisplatin,75mg/m(2), d1, 3 week, 2 cycles.
Procedure: surgery surgery
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Active Comparator: Surgery alone
Surgery alone
|
Procedure: surgery
surgery
|
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function:Total bilirubin ≤ 1.5x ULN;AST and ALT) ≤ 2.5x ULN Renal function:Cr ≤ 1.5x ULN,Ccr ≥ 55 ml/min Coagulation function:INR≤1.5×ULN, PT≤1.5ULN, APTT within the normal range
Exclusion Criteria:
| Contact: Junfeng Liu, PhD | 13931152296 | liujf@hbmu.edu |
| China, Hebei | |
| Jun Feng Liu | Recruiting |
| Shijiazhuang, Hebei, China, 050011 | |
| Contact: Jun Feng Liu, PhD 13931152296 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 18, 2019 | ||||
| First Posted Date ICMJE | May 28, 2019 | ||||
| Last Update Posted Date | August 15, 2019 | ||||
| Actual Study Start Date ICMJE | April 24, 2019 | ||||
| Estimated Primary Completion Date | June 24, 2026 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
OS [ Time Frame: up to 5 years ] Overall survival,From date of randomization until death due to any cause
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin for Locally Advanced Esophageal Squamous Cell Carcinoma | ||||
| Official Title ICMJE | The Effectiveness and Safety of Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin Followed by Surgery Versus Surgery Alone for Locally Advanced Esophageal Squamous Cell Carcinoma | ||||
| Brief Summary | To verify the role of nab-paclitaxel in neoadjuvant therapy for esophageal squamous cell carcinoma, the investigators designed a prospective, randomized, controlled , multicente phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as neoadjuvant therapy followed by surgery versus surgery alone for esophageal squamous cell carcinoma. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Esophageal Squamous Cell Carcinoma | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
202 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 24, 2026 | ||||
| Estimated Primary Completion Date | June 24, 2026 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function:Total bilirubin ≤ 1.5x ULN;AST and ALT) ≤ 2.5x ULN Renal function:Cr ≤ 1.5x ULN,Ccr ≥ 55 ml/min Coagulation function:INR≤1.5×ULN, PT≤1.5ULN, APTT within the normal range
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03964753 | ||||
| Other Study ID Numbers ICMJE | HebeiJLiu | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | LiuJunFeng, Hebei Medical University Fourth Hospital | ||||
| Study Sponsor ICMJE | Hebei Medical University Fourth Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Hebei Medical University Fourth Hospital | ||||
| Verification Date | August 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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