Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Cancer Patients (nabPCESCC)
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Purpose
The purpose of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Squamous Cell Carcinoma |
Drug: albumin-bound paclitaxel plus cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter,Phase ⅡStudy of Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin for Stage Ⅱ-Ⅲ Esophageal Squamous Cell Carcinoma Patients |
- response to induction therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]The response to induction therapy will be evaluated
- rate of complete pathological response [ Time Frame: 2 years ] [ Designated as safety issue: No ]The rate of complete pathological response will be evaluated
- R0 resection rate. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Complete resection rate to pre-operative chemotherapy will be assessed
- 3 years disease free and overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Three years disease free and overall survival will be evaluated.
- safety and tolerability [ Time Frame: From time of consent to last visit ] [ Designated as safety issue: Yes ]To monitor the safety and tolerability by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in all subjects
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: nab-paclitaxel plus cisplatin |
Drug: albumin-bound paclitaxel plus cisplatin
neo-chemotherapy program:Albumin-bound paclitaxel:100 mg/m2, IV (in the vein) on days 1,8 of each 21 day cycle. Cisplatin 75mg/m2,IV DRIP on day 1 of each 21 day cycle.Number of Cycles: 2 cycles before operation.If it is effective ,2 cycles will be given in 6 weeks after radical resection.
Other Name: nab-paclitaxel
|
Detailed Description:
A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases.A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone.The neoadjuvant chemotherapy may improve overall survival. Neoadjuvant chemotherapy with administrations of paclitaxel combined with cisplatin or carboplatin has shown effectively.Nanoparticle albumin-bound (nab)-paclitaxel has better efficacy and practically eliminates the risk of hypersensitivity reactions associated with solvent-based paclitaxel.We try to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin for stage Ⅱ-Ⅲ esophageal squamous cell carcinoma patients.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologic diagnosis of squamous cell carcinoma of esophagus. Preoperative stage Ⅱ-Ⅲ by endoscopic ultrasound, CT of the chest and abdomen,and esophagogram.
- Age ranges from 18 to 70 years.
- Patients must not have received any prior anticancer therapy.
- Performance status of 0 to 1
- Estimated life expectancy of at least 6 months.
- Tumor can be measured according to RECIST criteria
- Signed informed consent document on file.
- Females with childbearing potential must have a negative serum pregnancy
- Adequate organ function including the following:
Bone marrow: Absolute neutrophil count (ANC) greater than or equal 1.5×109/L Platelets greater than or equal 80×109/L Haemoglobin greater than or equal 80g/L Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN Renal: calculated creatinine clearance rate≥60ml/min. test within 7 days prior to study enrollment.
Exclusion Criteria:
- Carcinoma at the upper part of esophagus
- Histologic diagnosis of adenocarcinoma of esophagus.
- Prior treatment for esophageal cancer.
- Active infection.
- Pregnant or breast feeding.
- History of significant neurological or mental disorder, including seizures or dementia.
- Prior invasive malignancy in 5 years (except for carcinoma in situ).
Contacts and Locations| Contact: Weimin Mao, MD | 0086-571-88122032 | maowm1218@163.com |
| Contact: Zhongyu Ma, MD | 0086-13777556534 | mazhy1@qq.com |
| China, Zhejiang | |
| Zhejiang Cancer Hospital | Recruiting |
| Hangzhou, Zhejiang, China, 310022 | |
| Contact: Weimin Mao, MD 0086-571-88122032 maowm1218@163.com | |
| Contact: Zhongyu Ma, MD 0086-13777556534 mazhy1@qq.com | |
| Principal Investigator: Weimin Mao, MD | |
| Study Chair: | Weimin Mao, MD | Zhejiang Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Zhejiang Cancer Hospital |
| ClinicalTrials.gov Identifier: | NCT01258192 History of Changes |
| Other Study ID Numbers: | ZhejiangCH-ESCC-01 |
| Study First Received: | December 3, 2010 |
| Last Updated: | June 26, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Zhejiang Cancer Hospital:
|
esophageal squamous cell carcinoma neoadjuvant chemotherapy albumin-bound paclitaxel cisplatin |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Esophageal Diseases Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Cisplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013