Status:
UNKNOWN
Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclita...
Detailed Description
Patient Population: Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1, M0 Scheme: Patients are randomized to 2 arms: Arm A: Paclitaxel/carboplatin and co...
Eligibility Criteria
Inclusion
- Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (\> 20cm from the incisors) or gastroesophageal junction are included.
- No distant metastases (M0).
- Patients will be stratified by stage (clinical N0 versus clinical N1).
- Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
- Resectable mediastinal nodes are eligible.
- No prior chemotherapy for this malignancy.
- No prior radiotherapy that would overlap the field(s) treated in this study.
- Patients with other malignancies are eligible only if \> 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
- Age \> 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.
Exclusion
- Cancers of the cervical esophagus (\< 20 cm are excluded).
- Tumours that have \> 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
- Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
- Patients with biopsy proven metastatic celiac nodes are ineligible.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01463501
Start Date
October 1 2011
End Date
December 1 2016
Last Update
May 14 2013
Active Locations (2)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022