Efficacy of Intensity Modulated Radiation Therapy After Surgery in Early Stage of Esophageal Carcinoma;

Esophageal Neoplasm Clinical Trial

— IMRT  

Official title:

Phase Ⅲ Study of Prophylactic Postoperative Intensity Modulated Radiation Therapy in Stage T2-3N0M0 Disease of Thoracic Esophageal Squamous Cell Carcinoma;

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01745107
• Other study ID #: Z121107001012004
• Secondary ID: Z121107001012004
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 2012
• Est. completion date: December 2021

Study information

• Verified date: January 2019
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 72 Years

Eligibility

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;

Related Conditions & MeSH terms

• Esophageal Cancer TNM Staging Distal Metastasis (M) M0
• 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 Neoplasm
• Esophageal Neoplasms

Intervention

Radiation:
• Prophylactic postoperative radiation therapy
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.

Locations

Country	Name	City	State
China	Cancer institute & Hospital,Chinese Academy of Medical Science	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Sichuan Cancer Hospital and Research Institute, Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

References & Publications (19)

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Qiao XY, Wang W, Zhou ZG, Gao XS, Chang JY. Comparison of efficacy of regional and extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):396-402. Epub 2007 Sep 12. — View Citation

Reeh M, Nentwich MF, von Loga K, Schade J, Uzunoglu FG, Koenig AM, Bockhorn M, Rosch T, Izbicki JR, Bogoevski D. An attempt at validation of the Seventh edition of the classification by the International Union Against Cancer for esophageal carcinoma. Ann Thorac Surg. 2012 Mar;93(3):890-6. doi: 10.1016/j.athoracsur.2011.11.035. Epub 2012 Jan 29. — View Citation

Ténière P, Hay JM, Fingerhut A, Fagniez PL. Postoperative radiation therapy does not increase survival after curative resection for squamous cell carcinoma of the middle and lower esophagus as shown by a multicenter controlled trial. French University Association for Surgical Research. Surg Gynecol Obstet. 1991 Aug;173(2):123-30. — View Citation

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Xiao ZF, Yang ZY, Liang J, Miao YJ, Wang M, Yin WB, Gu XZ, Zhang DC, Zhang RG, Wang LJ. Value of radiotherapy after radical surgery for esophageal carcinoma: a report of 495 patients. Ann Thorac Surg. 2003 Feb;75(2):331-6. — View Citation

Xiao ZF, Yang ZY, Miao YJ, Wang LH, Yin WB, Gu XZ, Zhang DC, Sun KL, Chen GY, He J. Influence of number of metastatic lymph nodes on survival of curative resected thoracic esophageal cancer patients and value of radiotherapy: report of 549 cases. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):82-90. — View Citation

Zhang Wencheng,Wang Qifeng,Xiao Zefen,et al.A efficacy analysis of intensity-modulated radiotherapy or three-dimensional conformal radiotherapy for resected thoracic esophageal squamous cell carcinoma.Chinese Journal of Radiation Oncology.2012,21(2):136-139.DOI:10.3760/cma.j.issn.1004-4221.2012.02.012.

Zieren HU, Müller JM, Jacobi CA, Pichlmaier H, Müller RP, Staar S. Adjuvant postoperative radiation therapy after curative resection of squamous cell carcinoma of the thoracic esophagus: a prospective randomized study. World J Surg. 1995 May-Jun;19(3):444-9. — View Citation

* Note: There are 19 references in all — Click here to view all references

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 5 years

External Links

•   It is a national center for cancer research and treatment. It is one of the clinical trial bases approved by the Food and Drug Administration of State (SFDA)