Clinical trial NCT05189054: Safety and Efficacy of SBRT in the Reirradiation for Ultra-central Thoracic Malignant Tumors
Official title: Safety and Efficacy of SBRT in the Reirradiation for Ultra-central Thoracic Malignant Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stereotactic Body Radiation Therapy
Irradiation; Reaction
Thoracic Tumor
Recurrent Cancer
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Toxcicties
timeFrame: From the beginning of the treatment to 3 years after the treatment.
measure: Local control time
timeFrame: From the beginning of the treatment to 3 years after the treatment.
Secondary outcomes:
measure: Overall survival time
timeFrame: From the beginning of the treatment to 3 years after the treatment.
measure: Disease progression time
timeFrame: From the beginning of the treatment to 3 years after the treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Junjie Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: