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

NCT ID: NCT05189054

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stereotactic Body Radiation Therapy Irradiation; Reaction Thoracic Tumor Recurrent Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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stereotacitic body radiation therapy

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Junjie Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhe Ji, M.D.

Role: CONTACT

008618710002823

Junjie Wang, M.D.

Role: CONTACT

008601082265921

Facility Contacts

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Junjie Wang, M.D.

Role: primary

00861082265921

Zhe Ji, M.D.

Role: backup

008618710002823

Other Identifiers

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BYSY-2021-SBRT-UC

Identifier Type: -

Identifier Source: org_study_id

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