An interventional study of Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation and Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation in Esophageal Carcinoma, Neoadjuvant Chemoradiotherapy and Surgery, sponsored by Zhejiang Cancer Hospital. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Zhejiang Cancer Hospital · Not applicable, Interventional, and Treatment
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.
1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's enrollment of 147 is above the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Zhejiang Cancer Hospital is the lead sponsor of 281 studies on the registry; 116 are open to participants now.
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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.
Neoadjuvant chemoradiation: RT: 50.4Gy/28F/5.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 6 wks; Surgery: 4-6 weeks after nCRT
Radiation: Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation
Neoadjuvant chemoradiation: RT: 41.4Gy/23F/4.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 5 wks; Surgery: 4-6 weeks after nCRT
Radiation: Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation
50.4Gy/28F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly
41.4Gy/23F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly
Progression free survival
Time from randomization to tumor progression or any deaths
Time frame: 2 year
R0 resection rate in each arm
no cancer cells seen microscopically at the resection margin
Time frame: analysis is completed 4 weeks after surgery
Complete pathological response rate
using the Chirieac grading system
Time frame: analysis is completed 4 weeks after surgery
Postoperative complications in each study arm
According to the NCI CTC3.0
Time frame: 30 and 90 days after surgery
Treatment failure pattern
including local recurrence or distant metastasis or both
Time frame: 2 year
Overall survival
by intention to treat and per protocol analyses in each study arm
Time frame: 5 year
Plan to share: Undecided
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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