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Trial Title:
Efficacy of Intensity Modulated Radiation Therapy After Surgery in Early Stage of Esophageal Carcinoma;
NCT ID:
NCT01745107
Condition:
Esophageal Neoplasm
Esophageal Cancer TNM Staging Primary Tumor (T) T2
Esophageal Cancer TNM Staging Primary Tumor (T) T3
Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0
Esophageal Cancer TNM Staging Distal Metastasis (M) M0
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
T2-3N0M0 disease of esophageal neoplasm
postoperative radiotherapy
intensity modulated radiation therapy
survival
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Prophylactic postoperative radiation therapy
Description:
Prescription dose of 95%planning target volume(PTV) 50.4Gy/1.8Gy/28fractions for
supraclavicular region and 95%PTV 56Gy/2Gy/28fractions for mediastinum which is delivered
in 2 months after surgery.
Arm group label:
surgery plus radiation
Other name:
Preventive postoperative radiotherapy
Summary:
The purpose of this study is to determine the efficacy of preventive intensity modulated
radiation therapy after surgery in stage T2-3N0M0 disease of thoracic esophageal squamous
cell carcinoma(UICC 7th edition) and to identify the subgroup benefiting from the
treatment.
Detailed description:
Although preoperative chemoradiation therapy followed by surgery is the most common
approach for patients with resectable esophageal cancer, the considerable number of
esophageal cancer patients received operation as the first treatment modality.
Accordingly, postoperative treatments have been playing an important role because of the
poor survival rates of the patients who have been treated with resection alone. The
existing data shows that the 5-yeal survival rate of stage T2-3N0M0(UICC 7th edition) of
thoracic esophageal squamous cell carcinoma(TESCC) after surgery is about 50% ,and
locoregional lymph nodes metastases is responsible for the main cause of failure while
distal metastases account for relatively less ratio. Therefore, the subclinical residual
tumor is affirmative even if the early disease has been undergone curable excision and
local adjuvant treatment may be essential. While we have proved the value of prophylactic
radiation therapy after radical esophagectomy for esophageal carcinoma with positive
lymph node metastases and stage Ⅲ disease, there is still lack of clear evidence for
prophylactic radiation therapy in stage T2-3N0M0 disease now. The comparison of
conventional 2-dimensional radiotherapy after operation versus surgery alone does not
show statistically significant difference for stage T2-3N0M0 disease in our previous
report. In the precise radiotherapy setting, more and more evidences of non-randomised
control study indicate the trend or preliminary results of dosimetric advantages of IMRT
translating into substantive benefits in both survival and locoregional control compared
with 3- dimensional conformal and 2-dimensional conventional radiotherapy for the
treatment of esophageal carcinoma, but it remains to be confirmed in the randomized
control study that whether the IMRT is effective to improve the clinical outcomes of
stage T2-3N0M0 patients of TESCC. In view of this, we designed the randomized controlled
trial to determine the clinical efficacy and toxicity of prophylactic IMRT after surgery
in stage T2-3N0M0 disease of TESCC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Stage T2-3N0M0 disease of TESCC patients confirmed by pathology studies who received
R0 operations in Cancer Institute & Hospital，CAMS；
- KPS≥70 before radiotherapy;
- Did not receive neoadjuvant or adjuvant treatment;
- No clear recurrent or metastatic lesions before radiotherapy;
- Intensity modulated radiation therapy(IMRT) is accepted;
- Regular follow-up.
Exclusion Criteria:
- Exploratory thoracotomy or palliative surgery;
- No clear recurrent or metastatic sites;
- Recurrence or metastasis is not certain;
- death of no definite cause.
- Irregular follow-up;
Gender:
All
Minimum age:
40 Years
Maximum age:
72 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer institute & Hospital，Chinese Academy of Medical Science
Address:
City:
Beijing
Zip:
100021
Country:
China
Start date:
October 2012
Completion date:
December 2021
Lead sponsor:
Agency:
Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
ChineseAMS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01745107
http://www.cicams.ac.cn
