Esophageal Carcinoma, Neoadjuvant Chemoradiotherapy, Surgery
Conditions
Keywords
Radiation dose
Brief summary
Esophageal cancer is one of the most common cancers worldwide, while more than half new cases and deaths occurred in China. Surgery is the main curative treatment for this disease, the 5-year survival of EC remains poor, since most diseases are diagnosed at advanced stages. In last decades, several large clinical trials and meta-analyses have demonstrated that neo-adjuvant chemoradiotherapy followed by surgery can significantly increase the overall survival of patients with EC compared with surgery alone, while no effect of nCRT was apparent on postoperative health-related quality of life . However, the optimal radiation dose and surgery timing are still unknown. The investigators hypothesize that patients who receive higher dose (50.4Gy/28F) of neoadjuvant chemoradiation will have better pathologic response and progress-free survival compared to lower dose (41.4Gy/23F) of chemoradiation followed by surgery.
Interventions
RADIATIONHigher dose (50.4Gy/28F) of neoadjuvant chemoradiation
50.4Gy/28F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly
RADIATIONLower dose (41.4Gy/23F) of neoadjuvant chemoradiation
41.4Gy/23F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Age:18-70 years Histologically verified squamous carcinoma of the thoracic esophagus. Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations. Tumors should be resectable or potentially resectable and without distant metastasis, as assessed before neoadjuvant CRT, including clinical stage T2-4N0M0 or T1-4N1M0 according to the 6th AJCC system. Joined the study voluntarily and signed informed consent form No surgical contraindications No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥10 g/dL, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL\<1.5 x ULN, ALT and AST ≤ 2.5 x ULN, creatinine≤1.5 x ULN
Exclusion criteria
Cervical esophageal cancer (The upper end of the lesion is in the esophagus of the cervical segment). Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy) proven metastatic supraclavicular or celiac nodes are ineligible. Invasion of the tracheobronchial tree or aorta Tracheoesophageal fistula Concurrent pregnancy or lactation Severe diabetes mellitus with poor blood glucose control History of a second malignancy Patients being unable to undergo esophageal reconstruction with gastric tube, due to prior surgery. Patients undergoing esophageal reconstruction with jejunum. Patients have allergy reaction or contraindications to taxanes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 2 year | Time from randomization to tumor progression or any deaths |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate in each arm | analysis is completed 4 weeks after surgery | no cancer cells seen microscopically at the resection margin |
| Complete pathological response rate | analysis is completed 4 weeks after surgery | using the Chirieac grading system |
| Postoperative complications in each study arm | 30 and 90 days after surgery | According to the NCI CTC3.0 |
| Treatment failure pattern | 2 year | including local recurrence or distant metastasis or both |
| Overall survival | 5 year | by intention to treat and per protocol analyses in each study arm |
Countries
China
Outcome results
None listed