Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02384811|
Recruitment Status : Active, not recruiting
First Posted : March 10, 2015
Last Update Posted : September 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Squamous Cell Carcinoma||Radiation: radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2019|
Experimental: Radiation group
A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks.
The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.
- Local control rate [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 5 year ]
- Safety: Frequencies of treatment-related adverse event categories by NCI-CTC [ Time Frame: 3 months ]Frequencies of treatment-related adverse event categories by NCI-CTC including Esophagitis,Pneumonitis/Bronchitis,Skin reaction in radiation fields,Nausea/vomiting,Leucopenia,Thrombocytopenia,Anemia,Fatigue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384811
|Shanghai Cancer Center|
|Shanghai, Shanghai, China, 200000|
|Cancer hospital Fudan University|
|Shanghai, Shanghai, China, 200032|
|Principal Investigator:||Jia-qing Xiang, M.M||Fudan University|