Clinical trial NCT01745107: Efficacy of Intensity Modulated Radiation Therapy After Surgery in Early Stage of Esophageal Carcinoma;
Official title: Phase Ⅲ Study of Prophylactic Postoperative Intensity Modulated Radiation Therapy in Stage T2-3N0M0 Disease of Thoracic Esophageal Squamous Cell Carcinoma;
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: 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
Keywords: T2-3N0M0 disease of esophageal neoplasm
postoperative radiotherapy
intensity modulated radiation therapy
survival
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Sichuan Cancer Hospital and Research Institute
name: Tianjin Medical University Cancer Institute and Hospital
First posted: 2012-12-07
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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;

Primary outcomes:
measure: Disease-free survival time
timeFrame: up to 3 years
Secondary outcomes:
measure: overall survival time
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer institute & Hospital，Chinese Academy of Medical Science
state: Beijing
Study officials:
affiliation: The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science
name: Zefen Xiao, MD
role: PRINCIPAL_INVESTIGATOR
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