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

NCT05189054 | Recruiting

• 1 other identifier: BYSY-2021-SBRT-UC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stereotactic Body Radiation Therapy; Irradiation; Reaction; Thoracic Tumor; Recurrent Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Overall survival time

  From the beginning of the treatment to 3 years after the treatment.

• Disease progression time

  From the beginning of the treatment to 3 years after the treatment.

Interventions

stereotacitic body radiation therapy RADIATION

The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Thoracic Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Junjie Wang, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Ji, M.D.

CONTACT

008618710002823; aschoff@163.com

Junjie Wang, M.D.

CONTACT

008601082265921; junjiewang_edu@sina.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 12, 2022
• Study Start: May 1, 2022
• Primary Completion: April 30, 2025
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available within 6 months of the study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)