Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin

Phase 3

Not yet recruiting

• Conditions: Positive Circumferential Resection Margin; Esophageal Squamous Cell Carcinoma
• Interventions: Radiation: radiation

• Registration Number: NCT03273647
• Lead Sponsor: Fudan University

Brief Summary

The purpose of this study is to determine the efficacy of adjuvant radiotherapy for esophageal squamous cell carcinoma with positive circumstantial resection margin.

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. In rectal cancer, the involvement of the circumferential resection margin (CRM) is one of the key factors for local recurrence and poor prognosis,based on reports in which CRM with \< 1mm was found to be prognostically significant, whereas the clinical and prognostic significance of the CRM involvement in EC has been investigated only in a few series showing conflicting results, as some studies suggest a significant influence of CRM. There is lack of clear evidence for prophylactic radiation therapy in positive Circumferential Resection Margin(CRM) patients of TESCC now. In view of this, the randomized controlled trial will determine the clinical efficacy and toxicity of adjuvant radiotherapy in positive Circumferential Resection Margin(CRM) for thoracic esophageal squamous cell carcinoma.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-04
• Study First Posted: 2017-09-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19
• Study Start: 2017-12-01
• Primary Completion: 2019-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with esophageal cancer who received R0 operations in Fudan University Shanghai Cancer Center and postoperative pathology: squamous cell cancer,positive Circumferential Resection Margin(CRM)+

• 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.

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery plus radiation	radiation	adjuvant radiotherapy is developed in this arm

Primary Outcome Measures

Name	Time	Method
Disease-free survival time	up to 3 years	including survival time from randomization to locoregional recurrence and to distal metastasis

Secondary Outcome Measures

Name	Time	Method
overall survival time	up to 3 years	survival time from randomization to death