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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Adjuvant Radiotherapy for T3N0M0 Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin(a Randomized Controlled Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03273647
• Other study ID #: ESO-CRM
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 4, 2017
• Last updated: October 18, 2017
• Start date: December 1, 2017
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2017
• Source: Fudan University
• Contact: Jiaqing Xiang, MD
• Phone: +86 13901992249
• Email: j.q.xiang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 18 Years

Eligibility

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.

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Positive Circumferential Resection Margin

Intervention

Radiation:
• radiation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival time	including survival time from randomization to locoregional recurrence and to distal metastasis	up to 3 years
Secondary	overall survival time	survival time from randomization to death	up to 3 years