A Study of SBRT for OligoMetastatic ESCC

NCT03000816 | Completed DMC

• 1 other identifier: ESO-Shanghai10
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma Metastatic

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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 Outcomes (2)

• Local control

  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

  The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years.

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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

Radiation: SBRT

Interventions

SBRT RADIATION

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.

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 32417405 DERIVED

Study Officials

• Kuaile Zhao, MD.

  Fudan Universtiy Shanghai Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2016
• First Posted: December 22, 2016
• Study Start: April 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)