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

January 29, 2019 updated by: Zefen Xiao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer institute & Hospital，Chinese Academy of Medical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Preventive postoperative radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival time
Time Frame: up to 3 years
including survival time from randomization to locoregional recurrence and to distal metastasis
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival time
Time Frame: up to 5 years
survival time from randomization to death
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Tianjin Medical University Cancer Institute and Hospital
Sichuan Cancer Hospital and Research Institute

Investigators

  • Principal Investigator: Zefen Xiao, MD, The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

December 1, 2018

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 6, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (Estimate)

December 7, 2012

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z121107001012004 (Other Identifier: Beijing Municipal Science & Technology Commission,China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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