Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus
Information source: Zhejiang University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Squamous Cell Carcinoma of Esophagus
Intervention: nanoparticle albumin-bound paclitaxel (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: Zhejiang University Official(s) and/or principal investigator(s): Qiong Zhao, MD, Principal Investigator, Affiliation: The first affiliated hospital, Zhejiang University
Summary
Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and
safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in
neoadjuvant therapy in esophageal cancer. The objective of this single-arm phase II trial
was to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound
paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell
carcinoma.
Clinical Details
Official title: A Phase II Trial of Neoadjuvant Chemotherapy With Nanoparticle Albumin-bound Paclitaxel and Fluorouracil Followed by Surgery in Patients With Locally Advanced Squamous Cell Carcinoma of Esophagus
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: response rate
Secondary outcome: Overall survivalProgression-free survival Adverse events
Detailed description:
In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy,
radiation, or both, for patients with surgically resectable esophageal carcinoma, but have
all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative
chemotherapy followed by radical surgery became one of the treatment strategies for
resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy
of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of
nanoparticle albumin-bound paclitaxel plus 5-fluorouracil as perioperative therapy for
patients with resectable esophageal carcinoma.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including
the gastroesophageal junction (Siewert type I)
- Locally advanced disease that is technically operable with curative intent (R0)
- T3, N0 OR T1-3, N+ OR T4, Nx
- No T1-2, N0
- No inoperable T4 (unequivocal organ involvement)
- No distant metastasis, including M1a lymph node status
- Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be
verified by fine-needle aspiration cytology
- No carcinoma of the cervical esophagus
- Obstructive tumors allowed
Exclusion Criteria:
- Not suitable to surgery
- cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
- early Esophageal Carcinoma(Stage I)
- complete esophageal obstruction,Esophageal perforation or hematemesis
- other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma
in situ
- pregnant or breast-feeding women or people during the birth-period who refused to
take contraceptives
- Uncontrolled seizures or psychiatric diseases, loss of control over their own
behavior
- History of serious allergic or castor oil allergy
- Patients who are not suitable to participate in the trial according to researchers
Locations and Contacts
The first affiliated hospital, Zhejiang University, Hangzhou, Zhejiang 310003, China
Additional Information
Starting date: January 2014
Last updated: March 4, 2015
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