Phase II Study of Neo-adjuvant Chemoradiotherapy for Squamous Cell Esophageal Cancer
|ClinicalTrials.gov Identifier: NCT02938195|
Recruitment Status : Unknown
Verified October 2016 by Jun Liu, Shanghai Chest Hospital.
Recruitment status was: Recruiting
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Chemoradiation Surgery||Radiation: radiotherapy Procedure: Surgery||Phase 2|
Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 480,000 new cases and 400,000 deaths occurred annually worldwide. In China, either new cases or deaths account for more than half of the world. Morever, over 90% of Chinese patients have esophageal squamous cell carcinoma (ESCC).
Surgery is the main treatment of this disease, but the prognosis of patients with locally advanced esophageal cancer is rather poor. As a result of surgery alone, the 5-year survival rate of about 25% has not changed significantly in several decades.
Neo-adjuvant chemoradiotherapy followed by surgery seems hopeful to improve the survival of EC. Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increased the overall survival of patients with EC compared with surgery alone. However,a recent meta-analysis has indicated that an increased risk of postoperative mortality and treatment-related mortality was apparent in ESCC with the treatment of neo-adjuvant chemoradiotherapy.
Compare to surgery alone,the advantage of neoadjuvant chemoradiotherapy is reflected in the significantly higher percentage of R0 resections and higher rate of pathological complete response.
Thus,the investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional radiation therapy or Intensity-modulated radiation therapy was performed. 1.8Gy/fraction, 5 fractions a week, with a total dose of 4140cgy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy:Patients will be concurrently administered with irradiation every 4 weeks with PF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) for 2 cycles.
Surgery:Patients will receive operation 4-8 weeks after chemoradiotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Optimum Design of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Experimental: experimental arm
PF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) every 4 weeks for 2 cycles concurrently with three-dimensional radiation therapy or intensity-modulated radiotherapy followed by surgery 4-8weeks after neoadjuvant therapy in a standard manner.
The clinical target volume of radiotherapy only includes the visible tumor and lymph nodes and the investigators wouldn't do any prophylactic radiation treatment.
Surgery would be done 4-8 weeks after neoadjuvant chemoradiotherapy.
- Percentage of patients completing adjuvant chemoradiotherapy and surgery [ Time Frame: 4-8weeks after surgery ]
- Percentage of R0 resection [ Time Frame: 4-8weeks after surgery ]
- Percentage of pathological complete response [ Time Frame: 4-8weeks after surgery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938195
|Contact: Jun Liu, Doctor||+862122200000 ext email@example.com|
|Shanghai Chest Hospital||Recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: Jun Liu, Doctor +862122200000 ext 3602 firstname.lastname@example.org|
|Study Director:||Xiaolong Fu, Ph.D||Department of Radiation Oncology,Shanghai Chest Hospital|