Esophageal Cancer
Conditions
Keywords
Esophageal cancer, Resectable, Neoadjuvant chemoradiotherapy, Adjuvant chemoradiotherapy
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 (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.
Interventions
OTHERNeoadjuvant chemoradiotherapy
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scores of Quality of life | 1 year | Assess the quality of life based on FACT-E. |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 1 year | Assess the safety and tolerability based on NCI CTC V4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival | 3 years | Three years disease free survival will be evaluated. |
| Overall Survival | 3 years | Three years overall survival will be evaluated. |
Countries
China
Contacts
Primary ContactWeimin Mao, MD.
Backup ContactYaping Xu, MD.
Outcome results
None listed