A Study of SBRT for OligoMetastatic ESCC

January 24, 2021 updated by: Kuai Le Zhao, MD, Fudan University

A Phase 2 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of OligoMetastatic Esophageal Squamous Cell Carcinoma

The aim of this phase II trial is to assess progress-free survival, local control, overall survival, safety and tolerability of SBRT to treat patients with oligometastases in esophageal squamous cell carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

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
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan Universtiy Shanghai Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with metastatic esophageal squamous cell carcinoma who have received initial treatment for the primary site including surgery or chemoradiotherapy. Primary tumor site without progression at registration. The sites of allowed metastases are: peripheral lung, central lung, medistinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic lymph node. All metastases not resected must be amenable to SBRT.
  2. 1-4 radiographically distinct metastases of any distribution in 2 or less allowed anatomical sites. The diameters of lesions should be less than or equal to 5cm.
  3. Initial treatment should be completed at least 3 months prior to study registration.
  4. All the metastases treated with SBRT should not be treated with surgery, radiation, radio frequency ablation or other regional therapeutic modalities prior to study registration. The other (s) lesions should have been surgically removed.
  5. Age ≥ 18. PS ECOG 0-2，wight loss<30% during the latest 6 months.
  6. Evaluation by a radiation oncologist that the patient could tolerate the treatment of SBRT.
  7. Patient must provide study specific informed consent prior to study entry.
  8. For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration.

Exclusion Criteria:

  1. Progression of primary tumor site at time of registration.
  2. Metastases with indistinct borders making targeting not feasible.
  3. Known brain metastases.
  4. Prior palliative radiotherapy to metastases.

  5. Metastases located within 3 cm of the previously irradiated structures:

    a).Spinal cord previously irradiated >80Gy(Biological equivalent dose with α/β=2), b).Brachial plexus previously irradiated to > 100Gy(Biological equivalent dose with α/β=2), c).Small intestine, large intestine, or stomach previously irradiated to > 90Gy (Biological equivalent dose with α/β=2), d).Whole lung previously irradiated with prior V20Gy > 30% (delivered in ≤ 3 Gy/fraction), e)Metastasis irradiated with SBRT.

  6. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
  7. Drug addiction,Alcoholism or AIDS.
  8. Patients with severe organ dysfunction or Acute bacterial or fungal infection who are considered not suitable to enroll the study at the time of registration.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm
Patients in this arm will receive a treatment of SBRT for their oligometastatic lesions.
Radiation: SBRT
Patients with 1-4 metastases located in less than 2 organs/ lymphatic drainage regions that are 5 cm or less from each other and simultaneously treated with SBRT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: The survival time from the date each patient enrolled to the date of progression or date of death from any cause, whichever came first, assessed up to 5 years
progression-free survival will be measured as time to either progression or death
The survival time from the date each patient enrolled to the date of progression or date of death from any cause, whichever came first, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control
Time Frame: the time from the date each patient enrolled to the date of local failure or the last follow-up, assessed up to 5 years.
Local control will be measured as time to local recurrence
the time from the date each patient enrolled to the date of local failure or the last follow-up, assessed up to 5 years.
overall survival
Time Frame: The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years.
Overall survival will be measured as time until death from any cause
The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years.

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Study Chair: Kuaile Zhao, MD., Fudan Universtiy Shanghai Cancer Center

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

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)

April 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

December 18, 2016

First Submitted That Met QC Criteria

December 18, 2016

First Posted (Estimate)

December 22, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 24, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESO-Shanghai10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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