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A Study of SBRT for OligoMetastatic ESCC

Primary Purpose

Esophageal Squamous Cell Carcinoma Metastatic

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

SBRT

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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.
Initial treatment should be completed at least 3 months prior to study registration.
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.
Age ≥ 18. PS ECOG 0-2，wight loss<30% during the latest 6 months.
Evaluation by a radiation oncologist that the patient could tolerate the treatment of SBRT.
Patient must provide study specific informed consent prior to study entry.
For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration.

Exclusion Criteria:

Progression of primary tumor site at time of registration.
Metastases with indistinct borders making targeting not feasible.
Known brain metastases.
Prior palliative radiotherapy to metastases.
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.
Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
Drug addiction,Alcoholism or AIDS.
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.

Sites / Locations

Fudan Universtiy Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm

Arm Description

Patients in this arm will receive a treatment of SBRT for their oligometastatic lesions.

Outcomes

Primary Outcome Measures

Progression-free survival

progression-free survival will be measured as time to either progression or death

Secondary Outcome Measures

Local control

Local control will be measured as time to local recurrence

overall survival

Overall survival will be measured as time until death from any cause

Full Information

NCT ID

NCT03000816

First Posted

December 18, 2016

Last Updated

January 24, 2021

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03000816

Brief Title

A Study of SBRT for OligoMetastatic ESCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

April 2015 (Actual)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma Metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Arm

Arm Type

Experimental

Arm Description

Patients in this arm will receive a treatment of SBRT for their oligometastatic lesions.

Intervention Type

Radiation

Intervention Name(s)

SBRT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression-free survival

Description

progression-free survival will be measured as time to either progression or death

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

Secondary Outcome Measure Information:

Title

Local control

Description

Local control will be measured as time to local recurrence

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.

Title

overall survival

Description

Overall survival will be measured as time until death from any cause

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. Initial treatment should be completed at least 3 months prior to study registration. 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. Age ≥ 18. PS ECOG 0-2，wight loss<30% during the latest 6 months. Evaluation by a radiation oncologist that the patient could tolerate the treatment of SBRT. Patient must provide study specific informed consent prior to study entry. For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration. Exclusion Criteria: Progression of primary tumor site at time of registration. Metastases with indistinct borders making targeting not feasible. Known brain metastases. Prior palliative radiotherapy to metastases. 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. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives. Drug addiction,Alcoholism or AIDS. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kuaile Zhao, MD.

Organizational Affiliation

Fudan Universtiy Shanghai Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Fudan Universtiy Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32417405

Citation

Liu Q, Zhu Z, Chen Y, Deng J, Ai D, Liu Q, Wang S, Wu S, Chen J, Zhao K. Phase 2 Study of Stereotactic Body Radiation Therapy for Patients with Oligometastatic Esophageal Squamous Cell Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Nov 1;108(3):707-715. doi: 10.1016/j.ijrobp.2020.05.003. Epub 2020 May 14.

Results Reference

derived

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A Study of SBRT for OligoMetastatic ESCC

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