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

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ClinicalTrials.gov Identifier: NCT01745107
Recruitment Status : Recruiting
First Posted : December 7, 2012
Last Update Posted : October 24, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
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 Radiation: Prophylactic postoperative radiation therapy Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ⅲ Study of Prophylactic Postoperative Intensity Modulated Radiation Therapy in Stage T2-3N0M0 Disease of Thoracic Esophageal Squamous Cell Carcinoma;
Study Start Date : October 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: surgery alone
No prophylactic postoperative radiation therapy,that is surgery alone is developed in this arm
Experimental: surgery plus radiation
Prophylactic postoperative radiation therapy is developed in this arm
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.
Other Name: Preventive postoperative radiotherapy

Outcome Measures

Primary Outcome Measures :
  1. Disease-free survival time [ Time Frame: up to 3 years ]
    including survival time from randomization to locoregional recurrence and to distal metastasis

Secondary Outcome Measures :
  1. overall survival time [ Time Frame: up to 5 years ]
    survival time from randomization to death

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745107

Contact: Zenfen Xiao, MD 8610-87787643 xiaozefen@sina.com
Contact: Wei Deng, MD 86-18813019080 sherrydw@126.com

China, Beijing
Cancer institute & Hospital,Chinese Academy of Medical Science Recruiting
Beijing, Beijing, China, 100021
Contact: Zefen Xiao, MD    8610-87787643    Xiaozefen@sina.com   
Contact: Wei Deng, MD    86-18813019080    sherrydw@126.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Sichuan Cancer Hospital and Research Institute
Tianjin Medical University Cancer Institute and Hospital
Principal Investigator: Zefen Xiao, MD The Department of Radiation Oncology ,Cancer Institute & Hospital,Chinese Academy of Medical Science
More Information

Additional Information:
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.

Responsible Party: Zefen Xiao, Clinical Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01745107     History of Changes
Other Study ID Numbers: Z121107001012004
Z121107001012004 ( Other Identifier: Beijing Municipal Science & Technology Commission,China )
First Posted: December 7, 2012    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Keywords provided by Zefen Xiao, Chinese Academy of Medical Sciences:
T2-3N0M0 disease of esophageal neoplasm
postoperative radiotherapy
intensity modulated radiation therapy

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases