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Radiotherapy should be carried out within 4 weeks after the first dose of PD-1 inhibitor; the radiotherapy method should be determined according to the patient's condition; PD-1 inhibitor and chemotherapy should refer to the actual product instructions

Radiotherapy combined with PD-1 inhibitors

Rongrong Zhou

This is a prospective, single-center observational clinical study aimed at the efficacy and safety of radiotherapy combined with PD-1 inhibitors and chemotherapy in the treatment of Chinese patients with symptomatic NSCLC with brain metastases.

Radiotherapy is carried out within 4 weeks after the first dose of PD-1 inhibitor; radiotherapy is determined according to the patient's condition; the use of PD-1 inhibitors and chemotherapy is based on the actual product instructions.

From December 2021 to December 2023, after the patients signed the informed consent, they will be included in this observational study after being assessed as meeting the inclusion criteria. A total of 20 cases are planned to be included for research analysis. All eligible patients meeting the inclusion and exclusion criteria will be invited to participate in this study. Patients included in the study will be solicited to allow efficacy evaluation and survival follow-up during the study and after treatment. Patients were considered to be on study unless the patient died, was withdrawn from the study, was lost to follow-up, or the study was terminated. Patients do not need to visit a doctor or receive evaluation specifically because of the study, and the study doctor evaluates the patients based on clinical practice.

Since this study is an observational study, the diagnosis and treatment process listed in the protocol is a clinically recommended process and is not mandatory. Treatment and clinical visit schedules for enrolled patients were determined by clinicians based on routine practice. This study collects patient information, including safety and efficacy data, based on routine diagnosis and treatment procedures. Although the protocol does not mandate clinical visits, physicians are encouraged to follow up patients who have not been seen for at least 6 months to collect treatment-related data and determine patient survival. Patients will be considered lost to follow-up if they have not been seen for at least 1 year.

Radiotherapy Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of NSCLC Patients With Symptomatic Brain Metastases

An Observational Study on the Efficacy and Safety of Radiotherapy Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of NSCLC Patients With Symptomatic Brain Metastases

Wu Jieping Medical Foundation

Xiangya Hospital of Central South University

patients in this group are treated with 3000 cGy in 10 daily fractions

patients in this group are treated with 1800 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

standard treatment

1800 cGy in 4 fractions administered twice a day

short course treatment

Alessio G Morganti, MD

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors

Standard treatment for brain metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 cGy twice a day) to demonstrate non-inferiority of this scheme

Short Course Radiation Therapy in Palliative Treatment of Brain Metastases

SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Brain Metastases: an Interventional, Randomised, Multicentric Study

Reduction of initial symptoms after radiotherapy, assessed with Likert scale (weakness, motor disorders, cognitive impairment, personality changes, loss of balance, seizures, changes in speech, vision, hearing, memory problems, nausea or vomiting are evaluated as none-mild-moderate-severe)

Incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria

Incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbility Scoring Schema

Changes in QoL after the treatment assessed using European Organization for Research and Treatment of Cancer (EORTC) questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the quality of life of palliative cancer care patients)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiotherapy Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of NSCLC Patients With Symptomatic Brain Metastases	NCT05638425	Non-small Cell ... Brain Metastase...	Radiotherapy co...	18 Years -	Xiangya Hospital of Central South University
Short Course Radiation Therapy in Palliative Treatment of Brain Metastases	NCT03525301	Brain Metastase... Radiotherapy Palliative Care	standard treatm... short course tr...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Radiotherapy Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of NSCLC Patients With Symptomatic Brain Metastases	NCT05638425	Non-small Cell ... Brain Metastase...	Radiotherapy co...	18 Years -	Xiangya Hospital of Central South University

Spots Global Cancer Trial Database for symptomatic brain metastases