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Trial Title:
Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer
NCT ID:
NCT01463501
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
Esophageal cancer
Resectable
Neoadjuvant chemoradiotherapy
Adjuvant chemoradiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Neoadjuvant chemoradiotherapy
Description:
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery,
consolidate paclitaxel/carboplatin 2 cycles.
Arm group label:
Neoadjuvant Treatment
Other name:
Neoadjuvant Treatment
Intervention type:
Other
Intervention name:
Adjuvant chemoradiotherapy
Description:
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f),
consolidate paclitaxel/carboplatin 2 cycles.
Arm group label:
Adjuvant Treatment
Other name:
Adjuvant Treatment
Summary:
This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy
(Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative
Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.
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 concurrent radiation (50.4Gy/28f) followed by surgery,
consolidate paclitaxel/carboplatin 2 cycles.
Arm B:
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f),
consolidate paclitaxel/carboplatin 2 cycles.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Weimin Mao, MD.
Phone:
+86-571-88122032
Email:
maowmzj1218@163.com
Contact backup:
Last name:
Yaping Xu, MD
Phone:
+86-571-88122082
Email:
xuyaping1207@gmail.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Yaping Xu, MD
Phone:
+86 0571 88122082
Email:
xuyaping1207@gmail.com
Start date:
October 2011
Completion date:
December 2016
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01463501
