Safety and Efficacy of SBRT in the Reirradiation for Ultra-central Thoracic Malignant Tumors

The reirradiation of thoracic tumor is difficult. The possibility of surgery or re course radiotherapy is very small. In the NCCN guideline, only systemic treatment is recommended. However, the effective rate of systemic treatment is low. SBRT has the characteristics of high dose in tumor target area and low dose in surrounding normal tissues. In theory, SBRT is more conducive to the protection of normal tissues and can potentially be used in the salvage treatment of recurrent lesions after radiotherapy. Even so, SBRT is still controversial in the rescue treatment of recurrent lung cancer after radiotherapy, especially for "ultral-central" lesions close to mediastinal structures (such as bronchus, esophagus and large blood vessels), which have a high probability of fatal side effects. However, a few studies on the application of SBRT in the reirradiation for ultral-central lung cancer have shown acceptable safety and efficacy. Generally speaking, there are few studies on SBRT in the treatment of recurrent ultral-central tumor with limited data. The purpose of this study is to further evaluate the efficacy and toxicities of SBRT in the treatment of recurrent ultral-central tumors after radiotherapy.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Cancer; Stereotactic Body Radiation Therapy; Thoracic Tumor; Irradiation; Reaction
• Intervention / Treatment: Radiation: stereotacitic body radiation therapy

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Junjie Wang, M.D.; Phone Number: 008601082265921; Email: junjiewang_edu@sina.cn
• Study Contact Backup: Name: Zhe Ji, M.D.; Phone Number: 008618710002823; Email: aschoff@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Junjie Wang, M.D.; Phone Number: 00861082265921; Email: junjiewang_edu@sina.cn
      • Contact: Zhe Ji, M.D.; Phone Number: 008618710002823; Email: aschoff@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent chest "ultral-central" malignant tumors after radiotherapy who received SBRT treatment in our department from 2022 to 2023 were expected to be enrolled.

Description

Inclusion Criteria:

• Pathological diagnosis is malignant tumor.
• The location of the target lesion belongs to the ultra-central type of chest.
• The target lesion had a history of radiotherapy, and the lesion diameter is ≤ 5cm.
• There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by previous treatment.
• KPS>70, no serious or uncontrolled underlying diseases, such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, and patients are expected to be tolerated by radiotherapy.

Exclusion Criteria:

• Poor basic pulmonary function or symptom correlation caused by various reasons, unable to lie flat or cooperate with treatment.
• The general condition is poor, and the expected survival time is less than 3 months.
• Psychiatric patients or poor compliance, unable to cooperate to complete treatment.
• For other reasons, the researcher believes that it is not suitable to participate in this trial.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxcicties	Adverse events of radiation of normal tissues (Including lung, trachea, bronchus, esophagus, blood vessels, ribs, spinal cord, brachial plexus).	From the beginning of the treatment to 3 years after the treatment.
Local control time	The time from the date of SBRT to the date of recurrence of the target tumor or the date of last observation.	From the beginning of the treatment to 3 years after the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival time	The time from the date of SBRT to the date of death from any cause or the date of last observation.	From the beginning of the treatment to 3 years after the treatment.
Disease progression time	The time from the date of SBRT to the date of disease progression from any cause or the date of last observation.	From the beginning of the treatment to 3 years after the treatment.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Junjie Wang, M.D., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: December 26, 2021
• First Submitted That Met QC Criteria: December 26, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Disease Attributes; Neoplasms; Recurrence; Thoracic Neoplasms
• Other Study ID Numbers: BYSY-2021-SBRT-UC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of the study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No